{
    "info": {
        "nct_id": "NCT05667194",
        "official_title": "A Phase 1 Study to Assess the Safety ,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of KH617 After SAD and MAD Administration for Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n\n  2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:\n\n  a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophil count≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.\n\n  5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria\n  1. Advanced Solid Tumors\n\n     1. Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no further standard treatment or for which the patient is not tolerated.\n     2. Patient has at least one measurable or evaluable target lesion by RECIST 1.1.\n     3. Patient has an ECOG status of 0 to 2.\n  2. Brain Metastases\n\n     1. Patient has at least one measurable or evaluable target lesion by RANO-BM.\n  3. rGBM\n\n     1. Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment.\n     2. Patient has at measurable or evaluable target lesion by RANO.\n     3. 4.Patient has a Karnofsky Performance score (KPS) ≥60.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1.Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases:\n\n  a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.\n\n  4. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis.\n\n  6. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.\n\n  9. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP)",
                    "criterion": "compliance with ICH-GCP",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local legislation",
                    "criterion": "compliance with local legislation",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:",
            "criterions": [
                {
                    "exact_snippets": "Patient is male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophil count≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥9g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥100×10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count≥1.5×10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Albumin ≥3.0g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤1.5×ULN",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN",
                    "criterion": "aspartate aminotransferase and alanine aminotransferase levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": [
                                "<2+",
                                "24-hour proteinuria<1g"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy)",
                    "criterion": "coagulation times",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment",
                    "criterion": "recovery from previous treatment-related toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": "≤grade 1 NCI-CTCAE 5.0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Advanced Solid Tumors",
            "criterions": [
                {
                    "exact_snippets": "Advanced Solid Tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no further standard treatment or for which the patient is not tolerated.",
            "criterions": [
                {
                    "exact_snippets": "histopathology and/or cytology diagnosed",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histopathology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable, locally advanced or metastatic malignant solid tumors",
                    "criterion": "tumor status",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        },
                        {
                            "requirement_type": "malignancy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which there is no further standard treatment",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for which the patient is not tolerated",
                    "criterion": "treatment tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient has at least one measurable or evaluable target lesion by RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Patient has at least one measurable or evaluable target lesion by RECIST 1.1.",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        },
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient has an ECOG status of 0 to 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG status of 0 to 2",
                    "criterion": "ECOG status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Brain Metastases",
            "criterions": [
                {
                    "exact_snippets": "Brain Metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patient has at least one measurable or evaluable target lesion by RANO-BM.",
            "criterions": [
                {
                    "exact_snippets": "Patient has at least one measurable or evaluable target lesion by RANO-BM.",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        },
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "RANO-BM"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. rGBM",
            "criterions": [
                {
                    "exact_snippets": "rGBM",
                    "criterion": "recurrent glioblastoma multiforme (rGBM)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment.",
            "criterions": [
                {
                    "exact_snippets": "histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "advanced malignant adult diffuse glioma"
                        }
                    ]
                },
                {
                    "exact_snippets": "unequivocal evidence of GBM recurrence/progression",
                    "criterion": "GBM recurrence/progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "following completion of standard treatment",
                    "criterion": "completion of standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient has at measurable or evaluable target lesion by RANO.",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable target lesion by RANO",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 4.Patient has a Karnofsky Performance score (KPS) ≥60.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance score (KPS) ≥60",
                    "criterion": "Karnofsky Performance score (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1.Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases:",
            "criterions": [
                {
                    "exact_snippets": "Patient has received extensive radiation therapy.",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients has the following infectious diseases:",
                    "criterion": "infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B surface antigen-positive",
                    "criterion": "Hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV-DNA test indicated active hepatitis B",
                    "criterion": "HBV-DNA test",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "active hepatitis B"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis c",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "AIDS or HIV antibody test is positive",
                    "criterion": "HIV antibody test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled active infection",
                    "criterion": "Infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration",
                    "criterion": "Blood beta-HCG pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "female with bearing potential",
                    "criterion": "Female with childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617",
                    "criterion": "Contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": "unwilling"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis.",
            "criterions": [
                {
                    "exact_snippets": "Patient is currently pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous phrenoblabia history",
                    "criterion": "phrenoblabia history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "currently phrenoblabia",
                    "criterion": "current phrenoblabia",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "schizophrenia",
                    "criterion": "schizophrenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "paranoia",
                    "criterion": "paranoia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "phobias",
                    "criterion": "phobias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "obsessive-compulsive disorder",
                    "criterion": "obsessive-compulsive disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "insomnia",
                    "criterion": "insomnia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Alzheimer's disease",
                    "criterion": "Alzheimer's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "behavioral volitional disorder",
                    "criterion": "behavioral volitional disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "postpartum mental disorder",
                    "criterion": "postpartum mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "paranoid mental disorder",
                    "criterion": "paranoid mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "organic psychosis",
                    "criterion": "organic psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.",
            "criterions": [
                {
                    "exact_snippets": "Patient has had another malignancy within the previous 5 years.",
                    "criterion": "another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has active cardiac or cerebrovascular disease.",
                    "criterion": "active cardiac or cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.",
                    "criterion": "participation in another investigational study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.",
            "criterions": [
                {
                    "exact_snippets": "Patient has severe sensitivity/allergic reaction to KH617.",
                    "criterion": "sensitivity/allergic reaction to KH617",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for inclusion",
                            "expected_value": "inappropriate in the investigator's opinion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}