{
    "info": {
        "nct_id": "NCT05194072",
        "official_title": "A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors",
        "inclusion_criteria": "For Parts A, B, and C:\n\n* Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:\n\n  * High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer\n  * HER2-negative, HR positive breast cancer\n  * Triple-negative breast cancer (TNBC)\n  * Endometrial carcinoma\n  * Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])\n  * Cholangiocarcinoma or gallbladder carcinoma\n  * Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.\n\nFor Part E:\n\n* Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing\n* Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS<10 by local testing\n* Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery\n\n  * Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option\n  * Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies.\n  * Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC\n  * Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC\n  * Tumor tissue is required for enrollment.\n  * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n  * Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * have no new or enlarging brain metastases\n  * and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting B7-H4\n* Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0\n* Corneal disease or injury requiring treatment or active monitoring",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "For Parts A, B, and C:",
            "criterions": [
                {
                    "exact_snippets": "Parts A, B, and C",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": [
                                "A",
                                "B",
                                "C"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
                    "criterion": "solid tumor type",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer",
            "criterions": [
                {
                    "exact_snippets": "High-grade serous epithelial ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "high-grade serous epithelial"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary peritoneal cancer",
                    "criterion": "peritoneal cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary"
                        }
                    ]
                },
                {
                    "exact_snippets": "fallopian tube cancer",
                    "criterion": "fallopian tube cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2-negative, HR positive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HER2-negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HR positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Triple-negative breast cancer (TNBC)",
            "criterions": [
                {
                    "exact_snippets": "Triple-negative breast cancer (TNBC)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "triple-negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endometrial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Endometrial carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])",
            "criterions": [
                {
                    "exact_snippets": "Non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Squamous cell carcinoma [SqCC]",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adenocarcinoma [AC]",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cholangiocarcinoma or gallbladder carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Cholangiocarcinoma",
                    "criterion": "cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gallbladder carcinoma",
                    "criterion": "gallbladder carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.",
            "criterions": [
                {
                    "exact_snippets": "Adenoid cystic carcinoma (ACC)",
                    "criterion": "Adenoid cystic carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic TNBC",
                    "criterion": "TNBC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "For Part E:",
            "criterions": [
                {
                    "exact_snippets": "Part E",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "E"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic TNBC",
                    "criterion": "TNBC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "CPS≥10 by local testing",
                    "criterion": "CPS",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS<10 by local testing",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic TNBC",
                    "criterion": "TNBC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "CPS<10 by local testing",
                    "criterion": "CPS",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery",
            "criterions": [
                {
                    "exact_snippets": "triple negative breast cancer",
                    "criterion": "breast cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "triple negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "residual disease following neoadjuvant therapy",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "definitive surgery",
                    "criterion": "definitive surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option",
            "criterions": [
                {
                    "exact_snippets": "disease that is relapsed or refractory",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant to SOC therapies",
                    "criterion": "intolerance to SOC therapies",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no appropriate SOC therapeutic option",
                    "criterion": "SOC therapeutic option",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies.",
            "criterions": [
                {
                    "exact_snippets": "disease that is relapsed",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "relapsed"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that is ... refractory",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant to SOC therapies",
                    "criterion": "tolerance to SOC therapies",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC",
            "criterions": [
                {
                    "exact_snippets": "no prior treatment for locally advanced unresectable or metastatic TNBC",
                    "criterion": "prior treatment for locally advanced unresectable or metastatic TNBC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC",
            "criterions": [
                {
                    "exact_snippets": "Participants must have completed at least 6 cycles of neoadjuvant therapy",
                    "criterion": "neoadjuvant therapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic TNBC",
                    "criterion": "TNBC",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor tissue is required for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Tumor tissue is required",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease per RECIST version 1.1 at baseline",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST version 1.1"
                        },
                        {
                            "requirement_type": "time",
                            "expected_value": "baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy within 3 years before the first dose of study drug.",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any evidence of residual disease from a previously diagnosed malignancy.",
                    "criterion": "residual disease from a previously diagnosed malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions are malignancies with a negligible risk of metastasis or death.",
                    "criterion": "malignancies with a negligible risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "negligible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:",
            "criterions": [
                {
                    "exact_snippets": "Known active central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment",
            "criterions": [
                {
                    "exact_snippets": "clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment",
                    "criterion": "clinical stability after brain metastasis treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* have no new or enlarging brain metastases",
            "criterions": [
                {
                    "exact_snippets": "no new or enlarging brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "growth",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days",
                    "criterion": "corticosteroid use for brain metastases symptoms",
                    "requirements": [
                        {
                            "requirement_type": "duration off medication",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": "Carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous receipt of an MMAE-containing agent or an agent targeting B7-H4",
            "criterions": [
                {
                    "exact_snippets": "Previous receipt of an MMAE-containing agent",
                    "criterion": "MMAE-containing agent",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous receipt of ... an agent targeting B7-H4",
                    "criterion": "agent targeting B7-H4",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0",
                    "criterion": "pre-existing neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Corneal disease or injury requiring treatment or active monitoring",
            "criterions": [
                {
                    "exact_snippets": "Corneal disease or injury",
                    "criterion": "corneal disease or injury",
                    "requirements": [
                        {
                            "requirement_type": "treatment or active monitoring",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}