{
    "info": {
        "nct_id": "NCT05725291",
        "official_title": "First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.\n* Age ≥18 years (at the time consent is obtained).\n* Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.\n* Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n* Patients must have at least one measurable lesion as per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Both male and female patients must agree to use effective contraceptive methods.\n* Patients must have adequate organ function.\n* Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.\n* Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior therapy with ADC based on Top1 inhibitor.\n* Central nervous system (CNS) metastasis.\n* Active or chronic skin disorder requiring systemic therapy.\n* History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.\n* Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.\n* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.\n* Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.\n* Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.\n* Prior allogeneic or autologous bone marrow transplantation.\n* Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.\n* Pregnant or breast-feeding females.\n\nNote: Other protocol defined Inclusion/Exclusion criteria apply.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.",
                "criterions": [
                    {
                        "exact_snippets": "willing and able to sign the ICF",
                        "criterion": "informed consent form (ICF)",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to sign the ICF",
                        "criterion": "informed consent form (ICF)",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adhere to the study visit schedule",
                        "criterion": "study visit schedule adherence",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adhere to ... other protocol requirements",
                        "criterion": "protocol adherence",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "willing and able to sign the ICF",
                                "criterion": "informed consent form (ICF)",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "willing and able to sign the ICF",
                                "criterion": "informed consent form (ICF)",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "adhere to the study visit schedule",
                        "criterion": "study visit schedule adherence",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adhere to ... other protocol requirements",
                        "criterion": "protocol adherence",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥18 years (at the time consent is obtained).",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed",
                        "criterion": "tumor confirmation",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        }
                    },
                    {
                        "exact_snippets": "unresectable advanced solid tumor",
                        "criterion": "tumor resectability",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unresectable advanced solid tumor",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    },
                    {
                        "exact_snippets": "Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer",
                        "criterion": "preferred tumor types",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "head and neck",
                                "non-small cell lung",
                                "esophageal",
                                "pancreatic",
                                "large cell lung",
                                "colorectal",
                                "cervical",
                                "breast",
                                "bladder",
                                "gastric",
                                "biliary tract",
                                "skin squamous cell",
                                "liver",
                                "basal cell cancer"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "histologically confirmed",
                                                "criterion": "tumor confirmation",
                                                "requirement": {
                                                    "requirement_type": "confirmation method",
                                                    "expected_value": "histologically"
                                                }
                                            },
                                            {
                                                "exact_snippets": "unresectable advanced solid tumor",
                                                "criterion": "tumor resectability",
                                                "requirement": {
                                                    "requirement_type": "resectability",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "unresectable advanced solid tumor",
                                        "criterion": "tumor stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "advanced"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "solid tumor",
                                "criterion": "tumor type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "solid"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer",
                        "criterion": "preferred tumor types",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "head and neck",
                                "non-small cell lung",
                                "esophageal",
                                "pancreatic",
                                "large cell lung",
                                "colorectal",
                                "cervical",
                                "breast",
                                "bladder",
                                "gastric",
                                "biliary tract",
                                "skin squamous cell",
                                "liver",
                                "basal cell cancer"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have undergone at least one systemic therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiologically or clinically determined progressive disease",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": [
                                "radiologically",
                                "clinically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no further standard therapy is available",
                        "criterion": "standard therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intolerable to standard therapy",
                        "criterion": "standard therapy tolerance",
                        "requirement": {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients who have undergone at least one systemic therapy",
                                "criterion": "systemic therapy",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "therapy"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "radiologically or clinically determined progressive disease",
                                "criterion": "progressive disease",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": [
                                        "radiologically",
                                        "clinically"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "no further standard therapy is available",
                                "criterion": "standard therapy availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "intolerable to standard therapy",
                                "criterion": "standard therapy tolerance",
                                "requirement": {
                                    "requirement_type": "tolerance",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have at least one measurable lesion as per RECIST version 1.1.",
                "criterions": [
                    {
                        "exact_snippets": "at least one measurable lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "as per RECIST version 1.1",
                        "criterion": "RECIST version",
                        "requirement": {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "at least one measurable lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "as per RECIST version 1.1",
                        "criterion": "RECIST version",
                        "requirement": {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "must agree to use a latex condom",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "even if they had a successful vasectomy",
                        "criterion": "vasectomy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "successful"
                        }
                    },
                    {
                        "exact_snippets": "while on study treatment and for at least 12 weeks after the last dose of the IMP",
                        "criterion": "contraceptive use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "while on study treatment and for at least 12 weeks after the last dose of the IMP"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "must agree to use a latex condom",
                                "criterion": "contraceptive use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "while on study treatment and for at least 12 weeks after the last dose of the IMP",
                                "criterion": "contraceptive use duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "while on study treatment and for at least 12 weeks after the last dose of the IMP"
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "even if they had a successful vasectomy",
                            "criterion": "vasectomy status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": "successful"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients must agree not to donate sperm",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "female patients must agree not to donate eggs",
                        "criterion": "egg donation",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients must agree not to donate sperm",
                                "criterion": "sperm donation",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "while on study treatment and for at least 12 weeks after the last dose of the IMP",
                                "criterion": "sperm donation duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "while on study treatment and for at least 12 weeks after the last dose of the IMP"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "female patients must agree not to donate eggs",
                                "criterion": "egg donation",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "while on study treatment and for at least 12 weeks after the last dose of the IMP",
                                "criterion": "egg donation duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "while on study treatment and for at least 12 weeks after the last dose of the IMP"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.",
                "criterions": [
                    {
                        "exact_snippets": "Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material)",
                        "criterion": "tumour tissue sample",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material)",
                        "criterion": "tumour tissue sample",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Key",
                "criterions": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Prior therapy with ADC based on Top1 inhibitor.",
                "criterions": [
                    {
                        "exact_snippets": "Prior therapy with ADC based on Top1 inhibitor.",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "ADC based on Top1 inhibitor"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior therapy with ADC based on Top1 inhibitor.",
                    "criterion": "prior therapy",
                    "requirement": {
                        "requirement_type": "type",
                        "expected_value": "ADC based on Top1 inhibitor"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Central nervous system (CNS) metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "Central nervous system (CNS) metastasis",
                        "criterion": "CNS metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Central nervous system (CNS) metastasis",
                    "criterion": "CNS metastasis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active or chronic skin disorder requiring systemic therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Active or chronic skin disorder",
                        "criterion": "skin disorder",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "chronic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "requiring systemic therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active or chronic skin disorder",
                                "criterion": "skin disorder",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "active",
                                        "chronic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "requiring systemic therapy",
                                "criterion": "systemic therapy",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.",
                "criterions": [
                    {
                        "exact_snippets": "History of Steven's Johnson's syndrome",
                        "criterion": "Steven's Johnson's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... Toxic Epidermal Necrolysis syndrome",
                        "criterion": "Toxic Epidermal Necrolysis syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of Steven's Johnson's syndrome",
                        "criterion": "Steven's Johnson's syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... Toxic Epidermal Necrolysis syndrome",
                        "criterion": "Toxic Epidermal Necrolysis syndrome",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.",
                "criterions": [
                    {
                        "exact_snippets": "Active ocular conditions requiring treatment or close monitoring",
                        "criterion": "ocular conditions",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active ocular conditions requiring treatment or close monitoring",
                        "criterion": "ocular conditions",
                        "requirement": {
                            "requirement_type": "treatment or monitoring",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "macular degeneration",
                        "criterion": "macular degeneration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "papilledema",
                        "criterion": "papilledema",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active diabetic retinopathy with macular oedema",
                        "criterion": "diabetic retinopathy with macular oedema",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "wet age-related macular degeneration requiring intravitreal injections",
                        "criterion": "wet age-related macular degeneration",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "intravitreal injections"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled glaucoma",
                        "criterion": "glaucoma",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active ocular conditions requiring treatment or close monitoring",
                                "criterion": "ocular conditions",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            },
                            {
                                "exact_snippets": "Active ocular conditions requiring treatment or close monitoring",
                                "criterion": "ocular conditions",
                                "requirement": {
                                    "requirement_type": "treatment or monitoring",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "macular degeneration",
                        "criterion": "macular degeneration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "papilledema",
                        "criterion": "papilledema",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active diabetic retinopathy with macular oedema",
                        "criterion": "diabetic retinopathy with macular oedema",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "wet age-related macular degeneration requiring intravitreal injections",
                        "criterion": "wet age-related macular degeneration",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "intravitreal injections"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled glaucoma",
                        "criterion": "glaucoma",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.",
                "criterions": [
                    {
                        "exact_snippets": "Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.",
                        "criterion": "persistent toxicities from previous systemic anti-neoplastic treatments",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.",
                    "criterion": "persistent toxicities from previous systemic anti-neoplastic treatments",
                    "requirement": {
                        "requirement_type": "grade",
                        "expected_value": {
                            "operator": ">",
                            "value": 1,
                            "unit": "N/A"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.",
                "criterions": [
                    {
                        "exact_snippets": "Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.",
                        "criterion": "systemic anti-neoplastic therapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.",
                        "criterion": "systemic anti-neoplastic therapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.",
                "criterions": [
                    {
                        "exact_snippets": "Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months",
                        "criterion": "radiotherapy to lung field",
                        "requirement": {
                            "requirement_type": "total radiation dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Gy"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months",
                        "criterion": "radiotherapy to lung field",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    },
                    {
                        "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                        "criterion": "wide-field radiotherapy",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": "> 30% of marrow-bearing bones"
                        }
                    },
                    {
                        "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                        "criterion": "wide-field radiotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months",
                                        "criterion": "radiotherapy to lung field",
                                        "requirement": {
                                            "requirement_type": "total radiation dose",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 20,
                                                "unit": "Gy"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months",
                                        "criterion": "radiotherapy to lung field",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": "within 6 months"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                                        "criterion": "wide-field radiotherapy",
                                        "requirement": {
                                            "requirement_type": "extent",
                                            "expected_value": "> 30% of marrow-bearing bones"
                                        }
                                    },
                                    {
                                        "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                                        "criterion": "wide-field radiotherapy",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": "within 28 days"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                                "criterion": "wide-field radiotherapy",
                                "requirement": {
                                    "requirement_type": "extent",
                                    "expected_value": "> 30% of marrow-bearing bones"
                                }
                            },
                            {
                                "exact_snippets": "wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days",
                                "criterion": "wide-field radiotherapy",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 28 days"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery ... within 28 days prior to the first dose of the IMP",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no recovery from side effects of such intervention",
                        "criterion": "recovery from side effects of major surgery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Major surgery ... within 28 days prior to the first dose of the IMP",
                                "criterion": "major surgery",
                                "requirement": {
                                    "requirement_type": "time since surgery",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "no recovery from side effects of such intervention",
                                "criterion": "recovery from side effects of major surgery",
                                "requirement": {
                                    "requirement_type": "recovery",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "no recovery from side effects of such intervention",
                        "criterion": "recovery from side effects of major surgery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior allogeneic or autologous bone marrow transplantation.",
                "criterions": [
                    {
                        "exact_snippets": "Prior allogeneic or autologous bone marrow transplantation.",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "allogeneic",
                                "autologous"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Prior allogeneic or autologous bone marrow transplantation.",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior allogeneic or autologous bone marrow transplantation.",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "allogeneic",
                                "autologous"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Prior allogeneic or autologous bone marrow transplantation.",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.",
                "criterions": [
                    {
                        "exact_snippets": "Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction",
                        "criterion": "recent myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... acute coronary syndromes (including unstable angina pectoris)",
                        "criterion": "acute coronary syndromes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... congestive heart failure (New York Heart Association class III or IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association class III",
                                "New York Heart Association class IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... uncontrolled cardiac arrhythmias",
                        "criterion": "uncontrolled cardiac arrhythmias",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction",
                                "criterion": "recent myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Significant cardiac disease, such as ... acute coronary syndromes (including unstable angina pectoris)",
                                "criterion": "acute coronary syndromes",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... congestive heart failure (New York Heart Association class III or IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association class III",
                                "New York Heart Association class IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Significant cardiac disease, such as ... uncontrolled cardiac arrhythmias",
                        "criterion": "uncontrolled cardiac arrhythmias",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breast-feeding females.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Note: Other protocol defined Inclusion/Exclusion criteria apply.",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria apply.",
                        "criterion": "protocol defined Inclusion/Exclusion criteria",
                        "requirement": {
                            "requirement_type": "application",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria apply.",
                    "criterion": "protocol defined Inclusion/Exclusion criteria",
                    "requirement": {
                        "requirement_type": "application",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Key",
                "criterions": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Both male and female patients must agree to use effective contraceptive methods.",
                "criterions": [
                    {
                        "exact_snippets": "Both male and female patients must agree to use effective contraceptive methods.",
                        "criterion": "use of contraceptive methods",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Both male and female patients must agree to use effective contraceptive methods.",
                        "criterion": "use of contraceptive methods",
                        "requirement": {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have adequate organ function.",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.",
                "criterions": [
                    {
                        "exact_snippets": "Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}