{
    "info": {
        "nct_id": "NCT06459973",
        "official_title": "A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* 1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).\n\n  2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects.\n\n  5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.\n\n  10) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.\n\n  12) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.\n\n  3) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.\n\n  4) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.\n\n  5) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.\n\n  6) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.\n\n  7) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.\n\n  8) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.\n\n  9) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.\n\n  10) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.\n\n  11) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.\n\n  13) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.\n\n  15) Subjects with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.\n\n  16) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.\n\n  17) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.\n\n  18) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.\n\n  21) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.\n\n  22) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.\n\n  23) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).",
            "criterions": [
                {
                    "exact_snippets": "informed of relevant information of the study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily sign and date on the informed consent form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Be willing to follow and be able to complete all the study procedures",
                    "criterion": "willingness and ability to complete study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Body mass index (BMI) within the range of 18 to 32 kg/m2",
                    "criterion": "body mass index (BMI)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "kg/m2"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 32,
                                        "unit": "kg/m2"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "body weight ≥45kg for female subjects",
                    "criterion": "body weight for female subjects",
                    "requirements": [
                        {
                            "requirement_type": "minimum weight",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "locally advanced or metastatic ovarian cancer",
                                "non-squamous non-small cell lung cancer",
                                "renal cell carcinoma",
                                "endometrial cancer",
                                "other Napi2b-overexpressing tumors"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "positive Napi2b test results at the central laboratory",
                    "criterion": "Napi2b test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "At least one radiologically evaluable lesion for subjects in Part 1",
                    "criterion": "radiologically evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3",
                    "criterion": "measurable extracranial lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival ≥3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects of childbearing potential must agree to take effective contraceptive measures",
                    "criterion": "female contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects of childbearing potential ... must not undergo egg donation or egg retrieval for their own use",
                    "criterion": "female egg donation or retrieval",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects must agree to take effective contraceptive measures",
                    "criterion": "male contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects ... must not undergo sperm cryopreservation or sperm donation",
                    "criterion": "male sperm cryopreservation or donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "subjects must provide tumor samples",
                    "criterion": "tumor samples",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.",
            "criterions": [
                {
                    "exact_snippets": "Subjects with a treatment history with drugs targeting Napi2b.",
                    "criterion": "treatment history with drugs targeting Napi2b",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with a history of intolerance to topoisomerase I inhibitors",
                    "criterion": "intolerance to topoisomerase I inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with a history of intolerance to ... ADC therapy.",
                    "criterion": "intolerance to ADC therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.",
            "criterions": [
                {
                    "exact_snippets": "insufficient washout period from the previous anti-tumor therapy to the first dose",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who received major surgery within 4 weeks prior to the first dose",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "those who plan to receive major surgery during the study",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who received allogeneic bone marrow transplantation",
                    "criterion": "allogeneic bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who received ... solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who received systemic steroids",
                    "criterion": "systemic steroids",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who received ... other immunosuppressive treatment",
                    "criterion": "other immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who received any live vaccine within 4 weeks prior to the first dose",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "those who plan to receive live vaccines during the study",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "planned administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "medical history of leptomeningeal carcinoma",
                    "criterion": "leptomeningeal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... cancerous meningitis",
                    "criterion": "cancerous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.",
            "criterions": [
                {
                    "exact_snippets": "brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled or clinically significant cardiovascular ... diseases",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled or clinically significant ... cerebrovascular diseases",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significantly symptomatic or unstable effusion in the third space requiring repeated drainage",
                    "criterion": "effusion in the third space",
                    "requirements": [
                        {
                            "requirement_type": "symptom severity",
                            "expected_value": "significantly symptomatic"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "requiring repeated drainage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15) Subjects with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "medical history of gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... fistula within 6 months prior to the first dose",
                    "criterion": "fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to the first dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "active gastric ulcers",
                    "criterion": "gastric ulcers",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... duodenal ulcer",
                    "criterion": "duodenal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... colitis ulcerative",
                    "criterion": "colitis ulcerative",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "potential to cause hemorrhage or perforation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.",
            "criterions": [
                {
                    "exact_snippets": "serious infection (Grade ≥3 as per NCI CTCAE v5.0)",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade (NCI CTCAE v5.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.",
            "criterions": [
                {
                    "exact_snippets": "human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B virus (HBV)",
                    "criterion": "active HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus (HCV) infection",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive syphilis antibody and a positive titer result",
                    "criterion": "syphilis infection",
                    "requirements": [
                        {
                            "requirement_type": "antibody presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "titer result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicity caused by previous anti-tumor therapy",
                    "criterion": "toxicity from previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies",
                    "criterion": "serious allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "21) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects who are pregnant as confirmed by a pregnancy test",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.",
            "criterions": [
                {
                    "exact_snippets": "any diseases",
                    "criterion": "diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ system dysfunction",
                    "criterion": "organ system dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "social conditions",
                    "criterion": "social conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "23) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.",
            "criterions": [
                {
                    "exact_snippets": "multiple primary malignancies within 5 years prior to the signing of the ICF",
                    "criterion": "multiple primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fully resected non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "fully resected"
                        }
                    ]
                },
                {
                    "exact_snippets": "radically treated carcinoma in situ",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "radically treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "other radically treated solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "radically treated"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "3) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are participating in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of an observational (non-interventional) clinical study",
                    "criterion": "participation in observational clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the follow-up period of an interventional study",
                    "criterion": "participation in follow-up period of interventional study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}