{
    "info": {
        "nct_id": "NCT06712680",
        "official_title": "A Phase I/II , Open-label, Multi-center, Multi-cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HYP-6589 Monotherapy in Advanced Solid Tumors and Combination With Tyrosine Kinase Inhibitors in Patients With Advanced NSCLC With Target-driven Gene Positivity",
        "inclusion_criteria": "* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors;\n* At least one measurable lesion (according to RECIST 1.1 version);\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;\n* Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;\n* Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;\n* Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;\n* Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);\n* Participants who have received allogenic tissue/organ transplants in the past;\n* Participants with active infections deemed inappropriate for entry into the study by the investigator;\n* Participants with uncontrolled third-space effusion requiring clinical intervention;\n* Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;\n* Participants with known gastrointestinal (GI) dysfunction or GI diseases that are likely to significantly affect the absorption or metabolism of oral medications (e.g., dysphagia, active upper gastrointestinal ulcer, intestinal obstruction, nausea, vomiting, and diarrhea of grade 3 or higher that persist despite optimal supportive care within 3 days);\n* Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);\n* Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;\n* Known history of hypersensitivity to any of the components of the test formulation.\n* Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;",
                "criterions": [
                    {
                        "exact_snippets": "Voluntarily sign an informed consent form",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "understand the study",
                        "criterion": "study understanding",
                        "requirement": {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing and able to follow and complete all trial procedures",
                        "criterion": "trial procedure compliance",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Voluntarily sign an informed consent form",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "understand the study",
                        "criterion": "study understanding",
                        "requirement": {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing and able to follow and complete all trial procedures",
                        "criterion": "trial procedure compliance",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one measurable lesion (according to RECIST 1.1 version);",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable lesion (according to RECIST 1.1 version)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable lesion (according to RECIST 1.1 version)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1 version"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least one measurable lesion (according to RECIST 1.1 version)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable lesion (according to RECIST 1.1 version)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1 version"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy ≥3 months;",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant must have adequate main organ function;",
                "criterions": [
                    {
                        "exact_snippets": "adequate main organ function",
                        "criterion": "main organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate main organ function",
                        "criterion": "main organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.",
                "criterions": [
                    {
                        "exact_snippets": "Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing",
                        "criterion": "serological pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing",
                        "criterion": "serological pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before the first dosing"
                        }
                    },
                    {
                        "exact_snippets": "Fertile female patients ... be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study",
                        "criterion": "birth control/contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Fertile female patients ... be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study",
                        "criterion": "birth control/contraception",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study period up to 6 months after the last dosing"
                        }
                    },
                    {
                        "exact_snippets": "Male patients must agree to have no sperm donation plans",
                        "criterion": "sperm donation plans",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Male patients ... to use effective contraceptive methods during the study period until 6 months after the last dose of the study",
                        "criterion": "contraceptive methods",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Male patients ... to use effective contraceptive methods during the study period until 6 months after the last dose of the study",
                        "criterion": "contraceptive methods",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study period until 6 months after the last dose"
                        }
                    },
                    {
                        "exact_snippets": "Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile",
                        "criterion": "amenorrhea",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing",
                                                "criterion": "serological pregnancy test",
                                                "requirement": {
                                                    "requirement_type": "result",
                                                    "expected_value": "negative"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing",
                                                "criterion": "serological pregnancy test",
                                                "requirement": {
                                                    "requirement_type": "timing",
                                                    "expected_value": "within 7 days before the first dosing"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Fertile female patients ... be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study",
                                                "criterion": "birth control/contraception",
                                                "requirement": {
                                                    "requirement_type": "willingness",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "Fertile female patients ... be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study",
                                                "criterion": "birth control/contraception",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": "during the study period up to 6 months after the last dosing"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients must agree to have no sperm donation plans",
                                "criterion": "sperm donation plans",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Male patients ... to use effective contraceptive methods during the study period until 6 months after the last dose of the study",
                                        "criterion": "contraceptive methods",
                                        "requirement": {
                                            "requirement_type": "willingness",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Male patients ... to use effective contraceptive methods during the study period until 6 months after the last dose of the study",
                                        "criterion": "contraceptive methods",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "during the study period until 6 months after the last dose"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile",
                        "criterion": "amenorrhea",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;",
                "criterions": [
                    {
                        "exact_snippets": "undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug",
                        "criterion": "major organ surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "experienced significant trauma",
                        "criterion": "significant trauma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "require elective major organ surgery (excluding biopsy) during the study period",
                        "criterion": "elective major organ surgery",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug",
                                "criterion": "major organ surgery",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "experienced significant trauma",
                        "criterion": "significant trauma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "require elective major organ surgery (excluding biopsy) during the study period",
                        "criterion": "elective major organ surgery",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants who have received allogenic tissue/organ transplants in the past;",
                "criterions": [
                    {
                        "exact_snippets": "Participants who have received allogenic tissue/organ transplants",
                        "criterion": "allogenic tissue/organ transplants",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participants who have received allogenic tissue/organ transplants",
                    "criterion": "allogenic tissue/organ transplants",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants with active infections deemed inappropriate for entry into the study by the investigator;",
                "criterions": [
                    {
                        "exact_snippets": "active infections",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "appropriateness for study entry",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "active infections",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "appropriateness for study entry",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with uncontrolled third-space effusion requiring clinical intervention;",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled third-space effusion requiring clinical intervention",
                        "criterion": "third-space effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled third-space effusion requiring clinical intervention",
                        "criterion": "third-space effusion",
                        "requirement": {
                            "requirement_type": "intervention",
                            "expected_value": "requiring clinical intervention"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "uncontrolled third-space effusion requiring clinical intervention",
                        "criterion": "third-space effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled third-space effusion requiring clinical intervention",
                        "criterion": "third-space effusion",
                        "requirement": {
                            "requirement_type": "intervention",
                            "expected_value": "requiring clinical intervention"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;",
                "criterions": [
                    {
                        "exact_snippets": "history of drug abuse",
                        "criterion": "drug abuse history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "medical, psychological, or social conditions that may interfere with study participation",
                        "criterion": "conditions interfering with study participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "medical, psychological, or social conditions that may ... impair the assessment of study outcomes",
                        "criterion": "conditions impairing assessment of study outcomes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "history of drug abuse",
                        "criterion": "drug abuse history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "medical, psychological, or social conditions that may interfere with study participation",
                                "criterion": "conditions interfering with study participation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "medical, psychological, or social conditions that may ... impair the assessment of study outcomes",
                                "criterion": "conditions impairing assessment of study outcomes",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "medical, psychological, or social conditions that may interfere with study participation",
                                "criterion": "conditions interfering with study participation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "medical, psychological, or social conditions that may ... impair the assessment of study outcomes",
                                "criterion": "conditions impairing assessment of study outcomes",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);",
                "criterions": [
                    {
                        "exact_snippets": "toxicities from previous anti-cancer therapy have not resolved",
                        "criterion": "toxicities from previous anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version",
                        "criterion": "toxicity resolution",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE 5.0 version"
                            }
                        }
                    },
                    {
                        "exact_snippets": "peripheral neuropathy, ≤grade 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "CTCAE 5.0 version"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "toxicities from previous anti-cancer therapy have not resolved",
                                    "criterion": "toxicities from previous anti-cancer therapy",
                                    "requirement": {
                                        "requirement_type": "resolution",
                                        "expected_value": true
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version",
                                    "criterion": "toxicity resolution",
                                    "requirement": {
                                        "requirement_type": "grade",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "CTCAE 5.0 version"
                                        }
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "peripheral neuropathy, ≤grade 2",
                            "criterion": "peripheral neuropathy",
                            "requirement": {
                                "requirement_type": "grade",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 2,
                                    "unit": "CTCAE 5.0 version"
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;",
                "criterions": [
                    {
                        "exact_snippets": "Female participants who are breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive urine or blood pregnancy test results during the screening period",
                        "criterion": "pregnancy test results",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "female participants who have a planned pregnancy",
                        "criterion": "planned pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "female participants who have a planned ... sperm donation",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "female participants who have a planned ... egg donation",
                        "criterion": "egg donation",
                        "requirement": {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Female participants who are breastfeeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "positive urine or blood pregnancy test results during the screening period",
                                "criterion": "pregnancy test results",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "positive"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "female participants who have a planned pregnancy",
                                "criterion": "planned pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "female participants who have a planned ... sperm donation",
                                "criterion": "sperm donation",
                                "requirement": {
                                    "requirement_type": "planned",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "female participants who have a planned ... egg donation",
                                "criterion": "egg donation",
                                "requirement": {
                                    "requirement_type": "planned",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known history of hypersensitivity to any of the components of the test formulation.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of hypersensitivity to any of the components of the test formulation.",
                        "criterion": "hypersensitivity to components of the test formulation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known history of hypersensitivity to any of the components of the test formulation.",
                    "criterion": "hypersensitivity to components of the test formulation",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;",
                "criterions": [
                    {
                        "exact_snippets": "Participants who have had other malignancies within the past 5 years",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "excluding cured cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    },
                    {
                        "exact_snippets": "excluding ... basal cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "excluding ... squamous cell carcinoma of the skin",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "excluding cured cervical carcinoma in situ",
                                    "criterion": "cervical carcinoma in situ",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": "cured"
                                    }
                                },
                                {
                                    "exact_snippets": "excluding ... basal cell carcinoma of the skin",
                                    "criterion": "basal cell carcinoma of the skin",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "excluding ... squamous cell carcinoma of the skin",
                                    "criterion": "squamous cell carcinoma of the skin",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Participants who have had other malignancies within the past 5 years",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* ≥18 years old and ≤80 years old, gender: male or female;",
                "criterions": [
                    {
                        "exact_snippets": "≥18 years old and ≤80 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "gender: male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "\u0018 years old and \u0018 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "gender: male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors;",
                "criterions": [
                    {
                        "exact_snippets": "Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors",
                        "criterion": "unresectable and/or metastatic advanced solid tumors",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors",
                                "criterion": "unresectable and/or metastatic advanced solid tumors",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histological"
                                }
                            },
                            {
                                "exact_snippets": "Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors",
                                "criterion": "unresectable and/or metastatic advanced solid tumors",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "cytological"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;",
                "criterions": [
                    {
                        "exact_snippets": "Participants who have received other investigational drugs",
                        "criterion": "receipt of investigational drugs",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to the first administration of the study drug"
                        }
                    },
                    {
                        "exact_snippets": "participated in interventional medical device studies",
                        "criterion": "participation in interventional medical device studies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to the first administration of the study drug"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;",
                "criterions": [
                    {
                        "exact_snippets": "Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug",
                        "criterion": "live vaccine administration",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled, unstable, or active central nervous system (CNS) metastases",
                        "criterion": "central nervous system (CNS) metastases",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "uncontrolled",
                                "unstable",
                                "active"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "uncontrolled, unstable, or active central nervous system (CNS) metastases",
                        "criterion": "central nervous system (CNS) metastases",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled, unstable, or active central nervous system (CNS) metastases",
                        "criterion": "central nervous system (CNS) metastases",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled, unstable, or active central nervous system (CNS) metastases",
                        "criterion": "central nervous system (CNS) metastases",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);",
                "criterions": [
                    {
                        "exact_snippets": "clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "antihypertensive treatment"
                        }
                    },
                    {
                        "exact_snippets": "clinically significant by the investigator",
                        "criterion": "clinical significance",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "considered clinically significant by the investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants with known gastrointestinal (GI) dysfunction or GI diseases that are likely to significantly affect the absorption or metabolism of oral medications (e.g., dysphagia, active upper gastrointestinal ulcer, intestinal obstruction, nausea, vomiting, and diarrhea of grade 3 or higher that persist despite optimal supportive care within 3 days);",
                "criterions": [
                    {
                        "exact_snippets": "known gastrointestinal (GI) dysfunction or GI diseases",
                        "criterion": "gastrointestinal dysfunction or diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "likely to significantly affect the absorption or metabolism of oral medications",
                        "criterion": "effect on absorption or metabolism of oral medications",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "dysphagia",
                        "criterion": "dysphagia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active upper gastrointestinal ulcer",
                        "criterion": "active upper gastrointestinal ulcer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "nausea",
                        "criterion": "nausea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "vomiting",
                        "criterion": "vomiting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diarrhea of grade 3 or higher",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "persist despite optimal supportive care within 3 days",
                        "criterion": "persistence despite optimal supportive care",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "within 3 days"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}