{
    "info": {
        "nct_id": "NCT06310382",
        "official_title": "A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH55 in Patients Harboring MAPK Pathway Mutations in Advanced Solid Tumors",
        "inclusion_criteria": "Subjects must meet all the following inclusion criteria to be qualified for study enrollment:\n\n1. Male or female subjects aged 18-80 years (inclusive).\n2. Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS/RAF/MEK/ERK mutations) locally advanced or metastatic solid tumors.\n3. Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently.\n4. Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1. Phase II dose expansion: 0-2.\n6. 3 months or longer expected survival.\n7. Major organs are functioning normally, and laboratory tests meet the following criteria during the screening period.\n\nHematological system (has not received any blood transfusion or hematopoietic stimulating factor therapy within the past 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet Count (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Liver function Albumin (ALB) ≥ 3.0 g/dL Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) Liver metastasis or liver cancer patients: ≤ 2.5 × ULN Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Renal function Creatinine clearance rate (Ccr) ≥ 60 mL/min (calculated based on the Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50% QT interval corrected by the Fridericia formula (QTcF) Males < 450 ms, Females < 470 ms 7. Qualified patients (male and female) with childbearing potential must agree to use reliable contraceptives (hormone or barrier or abstinence) with their partners during the study and until at least 3 months after the last dose; female patients with childbearing potential must be negative for the blood pregnancy test within 1 week before the first dose.\n\n8. Subjects must give informed consent to the study and voluntarily signed the informed consent form prior to study initiation.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "Subjects who meet any one of the following exclusion criteria are not eligible for study enrollment:\n\n1. Received antitumor therapy such as chemotherapy within 3 weeks before the first dose, radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose, except for the following:\n\n   * Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;\n   * Use of oral fluorouracil(s), small molecule targeted drugs, and antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug;\n   * Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.\n2. Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.\n3. Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first dose or requires selective surgery during the study period.\n4. Use of strong CYP3A4 inhibitors or inducers within 1 week prior to the first dose of the investigational drug.\n5. Previously received other selective ERK inhibitors.\n6. Previously received allogeneic HSCT or organ transplantation.\n7. Adverse drug reactions of previous antitumor treatment have not recovered to grade ≤ 1 as per CTCAE version 5.0 (except for toxicity without safety risk judged by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism that is stable after hormone replacement therapy).\n8. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms unsuitable for study participation as judged by the investigator.\n9. Patient with active infection and currently requires intravenous anti-infective therapy.\n10. History of immunodeficiency, including being positive for HIV antibody test.\n11. Active hepatitis B [HBsAg positive and HBV-DNA > 500 IU/mL or LLQ of the study site (when the LLQ is > 500 IU/mL)], for which antiviral therapies other than interferon are permitted; Active hepatitis C (patients who are positive for HCV antibody but whose HCV-RNA is < study site LLQ can be included).\n12. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    * Severe abnormalities in cardiac rhythm or conduction, such as ventricular arrhythmia or second- or third-degree atrioventricular block requiring clinical intervention;\n    * Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to the first dose;\n    * New York Heart Disease Association (NYHA) class ≥ III cardiac function or left ventricular ejection fraction (LVEF) < 50%;\n    * Clinically uncontrolled hypertension;\n    * Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia that is difficult to correct, congenital long QT syndrome, family history of long QT syndrome, and use of concomitant medication known to prolong QT interval.\n13. History of other malignant tumors (except for the cured squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical carcinoma in situ that have not recurred within 5 years and are considered acceptable for study enrollment by the investigator; except for patients who are considered acceptable for enrollment by the investigator in the dose escalation study).\n14. History of retinal vein occlusion or central serous retinopathy, or patients with clinically significant abnormalities in the ophthalmological examination during the screening period and judged by the investigator to be unsuitable for enrollment.\n15. Unable to swallow medication or has conditions that severely impact gastrointestinal absorption (e.g. Chronic diarrhea or intestinal obstruction) as judged by the investigator.\n16. Clinically uncontrolled third space effusion judged by the investigator to be unsuitable for enrollment.\n17. Patients with current interstitial lung disease (except radiation-induced pulmonary fibrosis that does not required hormone therapy).\n18. Known alcohol or drug dependence.\n19. Mental disorder or poor compliance.\n20. Previous history of severe allergy, or allergy to any active or non-active ingredients of the investigational drug.\n21. Pregnant or lactating women.\n22. Other conditions judged by the investigator that render the subject unsuitable for participation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female subjects aged 18-80 years (inclusive).",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18-80 years (inclusive)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS/RAF/MEK/ERK mutations) locally advanced or metastatic solid tumors.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "MAPK mutant (presence of RAS/RAF/MEK/ERK mutations)",
                    "criterion": "MAPK mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic solid tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have failed standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "have no standard treatment regimen",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "are not suitable for standard treatment currently",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy).",
            "criterions": [
                {
                    "exact_snippets": "Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1",
                    "criterion": "assessable tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "assessment standard",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1",
                    "criterion": "measurable tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "assessment standard",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy",
                    "criterion": "tumor lesion in region of previous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "condition for measurability",
                            "expected_value": [
                                "clear progression",
                                "persists for 3 months after radiotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1. Phase II dose expansion: 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1.",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score: ... Phase II dose expansion: 0-2.",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. 3 months or longer expected survival.",
            "criterions": [
                {
                    "exact_snippets": "3 months or longer expected survival",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Major organs are functioning normally, and laboratory tests meet the following criteria during the screening period.",
            "criterions": [
                {
                    "exact_snippets": "Major organs are functioning normally",
                    "criterion": "major organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory tests meet the following criteria",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "met"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematological system (has not received any blood transfusion or hematopoietic stimulating factor therapy within the past 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet Count (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Liver function Albumin (ALB) ≥ 3.0 g/dL Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) Liver metastasis or liver cancer patients: ≤ 2.5 × ULN Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Renal function Creatinine clearance rate (Ccr) ≥ 60 mL/min (calculated based on the Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50% QT interval corrected by the Fridericia formula (QTcF) Males < 450 ms, Females < 470 ms 7. Qualified patients (male and female) with childbearing potential must agree to use reliable contraceptives (hormone or barrier or abstinence) with their partners during the study and until at least 3 months after the last dose; female patients with childbearing potential must be negative for the blood pregnancy test within 1 week before the first dose.",
            "criterions": [
                {
                    "exact_snippets": "Hematological system (has not received any blood transfusion or hematopoietic stimulating factor therapy within the past 14 days)",
                    "criterion": "hematological system",
                    "requirements": [
                        {
                            "requirement_type": "blood transfusion",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "hematopoietic stimulating factor therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 × 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet Count (PLT) ≥ 75 × 109/L",
                    "criterion": "platelet count (PLT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin (Hb) ≥ 90 g/L",
                    "criterion": "hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver function Albumin (ALB) ≥ 3.0 g/dL",
                    "criterion": "albumin (ALB)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver metastasis or liver cancer patients: ≤ 2.5 × ULN",
                    "criterion": "total bilirubin (TBIL) for liver metastasis or liver cancer patients",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        },
                        {
                            "requirement_type": "quantity for liver metastasis or liver cancer patients",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        },
                        {
                            "requirement_type": "quantity for liver metastasis or liver cancer patients",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal function Creatinine clearance rate (Ccr) ≥ 60 mL/min (calculated based on the Cockcroft-Gault formula)",
                    "criterion": "creatinine clearance rate (Ccr)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "International normalized ratio (INR) ≤ 1.5 × ULN",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QT interval corrected by the Fridericia formula (QTcF) Males < 450 ms, Females < 470 ms",
                    "criterion": "QT interval corrected by the Fridericia formula (QTcF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity for males",
                            "expected_value": {
                                "operator": "<",
                                "value": 450,
                                "unit": "ms"
                            }
                        },
                        {
                            "requirement_type": "quantity for females",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Qualified patients (male and female) with childbearing potential must agree to use reliable contraceptives (hormone or barrier or abstinence) with their partners during the study and until at least 3 months after the last dose",
                    "criterion": "use of reliable contraceptives",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female patients with childbearing potential must be negative for the blood pregnancy test within 1 week before the first dose",
                    "criterion": "blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects must give informed consent to the study and voluntarily signed the informed consent form prior to study initiation.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily signed the informed consent form",
                    "criterion": "informed consent form signature",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Received antitumor therapy such as chemotherapy within 3 weeks before the first dose, radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose, except for the following:",
            "criterions": [
                {
                    "exact_snippets": "Received antitumor therapy such as chemotherapy within 3 weeks before the first dose",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose",
                    "criterion": "biotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;",
            "criterions": [
                {
                    "exact_snippets": "Use of nitrosoureas ... within 6 weeks prior to the first dose of the investigational drug",
                    "criterion": "nitrosoureas use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of ... mitomycin C within 6 weeks prior to the first dose of the investigational drug",
                    "criterion": "mitomycin C use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of oral fluorouracil(s), small molecule targeted drugs, and antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug;",
            "criterions": [
                {
                    "exact_snippets": "Use of oral fluorouracil(s) ... within 2 weeks prior to the first dose of the investigational drug",
                    "criterion": "oral fluorouracil use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of ... small molecule targeted drugs ... within 2 weeks prior to the first dose of the investigational drug",
                    "criterion": "small molecule targeted drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of ... antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug",
                    "criterion": "antitumor traditional Chinese medicine use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.",
                    "criterion": "local palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.",
            "criterions": [
                {
                    "exact_snippets": "Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.",
                    "criterion": "receipt of unmarketed clinical investigational drug or therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first dose or requires selective surgery during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Underwent major organ surgery (excluding needle biopsy) ... within 4 weeks prior to the first dose",
                    "criterion": "major organ surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had significant trauma within 4 weeks prior to the first dose",
                    "criterion": "significant trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since trauma",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "requires selective surgery during the study period",
                    "criterion": "selective surgery",
                    "requirements": [
                        {
                            "requirement_type": "requirement for surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Use of strong CYP3A4 inhibitors or inducers within 1 week prior to the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Use of strong CYP3A4 inhibitors",
                    "criterion": "use of strong CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week prior to the first dose of the investigational drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of strong CYP3A4 ... inducers",
                    "criterion": "use of strong CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week prior to the first dose of the investigational drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Previously received other selective ERK inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Previously received other selective ERK inhibitors",
                    "criterion": "previous treatment with selective ERK inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Previously received allogeneic HSCT or organ transplantation.",
            "criterions": [
                {
                    "exact_snippets": "Previously received allogeneic HSCT",
                    "criterion": "allogeneic HSCT",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously received ... organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adverse drug reactions of previous antitumor treatment have not recovered to grade ≤ 1 as per CTCAE version 5.0 (except for toxicity without safety risk judged by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism that is stable after hormone replacement therapy).",
            "criterions": [
                {
                    "exact_snippets": "Adverse drug reactions of previous antitumor treatment have not recovered to grade ≤ 1 as per CTCAE version 5.0",
                    "criterion": "adverse drug reactions of previous antitumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity without safety risk judged by the investigator, such as alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity without safety risk judged by the investigator, such as ... grade 2 peripheral neurotoxicity",
                    "criterion": "grade 2 peripheral neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity without safety risk judged by the investigator, such as ... hypothyroidism that is stable after hormone replacement therapy",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms unsuitable for study participation as judged by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Brain parenchymal metastasis",
                    "criterion": "brain parenchymal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "clinical symptoms",
                            "expected_value": "unsuitable for study participation as judged by the investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "clinical symptoms",
                            "expected_value": "unsuitable for study participation as judged by the investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient with active infection and currently requires intravenous anti-infective therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patient with active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requires intravenous anti-infective therapy",
                    "criterion": "intravenous anti-infective therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of immunodeficiency, including being positive for HIV antibody test.",
            "criterions": [
                {
                    "exact_snippets": "History of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive for HIV antibody test",
                    "criterion": "HIV antibody test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Active hepatitis B [HBsAg positive and HBV-DNA > 500 IU/mL or LLQ of the study site (when the LLQ is > 500 IU/mL)], for which antiviral therapies other than interferon are permitted; Active hepatitis C (patients who are positive for HCV antibody but whose HCV-RNA is < study site LLQ can be included).",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B [HBsAg positive and HBV-DNA > 500 IU/mL or LLQ of the study site (when the LLQ is > 500 IU/mL)]",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HBsAg",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HBV-DNA",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 500,
                                        "unit": "IU/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis C (patients who are positive for HCV antibody but whose HCV-RNA is < study site LLQ can be included)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HCV antibody",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HCV-RNA",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 0,
                                        "unit": "study site LLQ"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "History of severe cardiovascular ... diseases",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of severe ... cerebrovascular diseases",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe abnormalities in cardiac rhythm or conduction, such as ventricular arrhythmia or second- or third-degree atrioventricular block requiring clinical intervention;",
            "criterions": [
                {
                    "exact_snippets": "Severe abnormalities in cardiac rhythm or conduction",
                    "criterion": "cardiac rhythm or conduction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "second- or third-degree atrioventricular block",
                    "criterion": "atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "degree",
                            "expected_value": [
                                "second",
                                "third"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring clinical intervention",
                    "criterion": "clinical intervention",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Acute coronary syndrome ... within 6 months prior to the first dose",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure ... within 6 months prior to the first dose",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aortic dissection ... within 6 months prior to the first dose",
                    "criterion": "aortic dissection",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke ... within 6 months prior to the first dose",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to the first dose",
                    "criterion": "cardiovascular and cerebrovascular events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 3 or greater"
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New York Heart Disease Association (NYHA) class ≥ III cardiac function or left ventricular ejection fraction (LVEF) < 50%;",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Disease Association (NYHA) class ≥ III cardiac function",
                    "criterion": "NYHA cardiac function class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) < 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically uncontrolled hypertension;",
            "criterions": [
                {
                    "exact_snippets": "Clinically uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "clinically uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia that is difficult to correct, congenital long QT syndrome, family history of long QT syndrome, and use of concomitant medication known to prolong QT interval.",
            "criterions": [
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypokalemia that is difficult to correct",
                    "criterion": "hypokalemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "difficult to correct"
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of long QT syndrome",
                    "criterion": "family history of long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of concomitant medication known to prolong QT interval",
                    "criterion": "use of concomitant medication known to prolong QT interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of other malignant tumors (except for the cured squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical carcinoma in situ that have not recurred within 5 years and are considered acceptable for study enrollment by the investigator; except for patients who are considered acceptable for enrollment by the investigator in the dose escalation study).",
            "criterions": [
                {
                    "exact_snippets": "History of other malignant tumors",
                    "criterion": "history of other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cured squamous cell carcinoma in situ of the skin",
                    "criterion": "cured squamous cell carcinoma in situ of the skin",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since recurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since recurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since recurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "considered acceptable for study enrollment by the investigator",
                    "criterion": "investigator's discretion for study enrollment",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered acceptable for enrollment by the investigator in the dose escalation study",
                    "criterion": "investigator's discretion for dose escalation study enrollment",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. History of retinal vein occlusion or central serous retinopathy, or patients with clinically significant abnormalities in the ophthalmological examination during the screening period and judged by the investigator to be unsuitable for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "History of retinal vein occlusion",
                    "criterion": "retinal vein occlusion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... central serous retinopathy",
                    "criterion": "central serous retinopathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormalities in the ophthalmological examination",
                    "criterion": "ophthalmological examination abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Unable to swallow medication or has conditions that severely impact gastrointestinal absorption (e.g. Chronic diarrhea or intestinal obstruction) as judged by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Unable to swallow medication",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions that severely impact gastrointestinal absorption",
                    "criterion": "gastrointestinal absorption",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Clinically uncontrolled third space effusion judged by the investigator to be unsuitable for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Clinically uncontrolled third space effusion",
                    "criterion": "third space effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "clinically uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients with current interstitial lung disease (except radiation-induced pulmonary fibrosis that does not required hormone therapy).",
            "criterions": [
                {
                    "exact_snippets": "Patients with current interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation-induced pulmonary fibrosis that does not required hormone therapy",
                    "criterion": "radiation-induced pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "does not require hormone therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Known alcohol or drug dependence.",
            "criterions": [
                {
                    "exact_snippets": "Known alcohol or drug dependence.",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known alcohol or drug dependence.",
                    "criterion": "drug dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Mental disorder or poor compliance.",
            "criterions": [
                {
                    "exact_snippets": "Mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "poor compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Previous history of severe allergy, or allergy to any active or non-active ingredients of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Previous history of severe allergy",
                    "criterion": "severe allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to any active or non-active ingredients of the investigational drug",
                    "criterion": "allergy to investigational drug ingredients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Other conditions judged by the investigator that render the subject unsuitable for participation.",
            "criterions": [
                {
                    "exact_snippets": "Other conditions judged by the investigator",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "judged by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Subjects must meet all the following inclusion criteria to be qualified for study enrollment:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Subjects who meet any one of the following exclusion criteria are not eligible for study enrollment:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}