{
    "info": {
        "nct_id": "NCT06276491",
        "official_title": "A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors",
        "inclusion_criteria": "* Age ≥ 18 years. For subjects with GCTs, age ≥15 years\n* CLDN6+ tumor\n* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT\n* Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.\n* Eastern Cooperative Oncology Group performance status of 0-2\n* Life expectancy ≥ 3 months\n* Adequate liver, kidney, and bone marrow function\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 15 Years",
        "exclusion_criteria": "* Prior exposure to a CLDN6 targeting product\n* Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy\n* Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.\n* Active known or suspected autoimmune disease\n* Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Clinically significant cardiovascular, pulmonary or gastrointestinal disease\n* Positive test for hepatitis C RNA\n* Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years. For subjects with GCTs, age ≥15 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For subjects with GCTs, age ≥15 years",
                    "criterion": "age for subjects with GCTs",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CLDN6+ tumor",
            "criterions": [
                {
                    "exact_snippets": "CLDN6+ tumor",
                    "criterion": "CLDN6 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer",
                    "criterion": "ovarian, fallopian tube, or peritoneal cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histological or cytological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological documentation of ... adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus)",
                    "criterion": "adenocarcinoma of the endometrium",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histological or cytological"
                        }
                    ]
                },
                {
                    "exact_snippets": "GCT",
                    "criterion": "GCT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.",
            "criterions": [
                {
                    "exact_snippets": "documented progressive disease (PD)",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exhausted therapies with a survival benefit",
                    "criterion": "therapies with a survival benefit",
                    "requirements": [
                        {
                            "requirement_type": "exhaustion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "standard therapy has no survival benefit",
                    "criterion": "standard therapy survival benefit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "proven to be ineffective",
                    "criterion": "standard therapy effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerable",
                    "criterion": "standard therapy tolerability",
                    "requirements": [
                        {
                            "requirement_type": "tolerability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "subject is not a candidate for such available therapy",
                    "criterion": "candidate for available therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group performance status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status of 0-2",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver, kidney, and bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... kidney ... function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior exposure to a CLDN6 targeting product",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to a CLDN6 targeting product",
                    "criterion": "CLDN6 targeting product exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum refractory",
                    "criterion": "platinum refractory",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rapid progression on most recent prior ≥ second line systemic anticancer therapy",
                    "criterion": "progression on systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "speed",
                            "expected_value": "rapid"
                        },
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.",
            "criterions": [
                {
                    "exact_snippets": "known active central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated brain metastases ... radiologically stable",
                    "criterion": "treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "radiologically stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active known or suspected autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Active known or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "certainty",
                            "expected_value": [
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications",
                    "criterion": "condition requiring systemic treatment with corticosteroids or immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to first dose of study drug",
                    "criterion": "time since last systemic treatment with corticosteroids or immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular, pulmonary or gastrointestinal disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular ... disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... pulmonary ... disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... gastrointestinal disease",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive test for hepatitis C RNA",
            "criterions": [
                {
                    "exact_snippets": "Positive test for hepatitis C RNA",
                    "criterion": "hepatitis C RNA",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)",
            "criterions": [
                {
                    "exact_snippets": "Positive test for hepatitis B surface antigen",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive test for ... hepatitis B core antibody (hBcAb)",
                    "criterion": "hepatitis B core antibody (hBcAb)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}