{
"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": [
{
"identified_line": {
"line": "For Parts A, B, and C:",
"criterions": [
{
"exact_snippets": "Parts A, B, and C",
"criterion": "trial part",
"requirement": {
"requirement_type": "participation",
"expected_value": [
"A",
"B",
"C"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Parts A, B, and C",
"criterion": "trial part",
"requirement": {
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"expected_value": [
"A",
"B",
"C"
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}
}
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}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "type",
"expected_value": "high-grade serous epithelial"
}
},
{
"exact_snippets": "primary peritoneal cancer",
"criterion": "peritoneal cancer",
"requirement": {
"requirement_type": "type",
"expected_value": "primary"
}
},
{
"exact_snippets": "fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "High-grade serous epithelial ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "type",
"expected_value": "high-grade serous epithelial"
}
},
{
"exact_snippets": "primary peritoneal cancer",
"criterion": "peritoneal cancer",
"requirement": {
"requirement_type": "type",
"expected_value": "primary"
}
},
{
"exact_snippets": "fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* HER2-negative, HR positive breast cancer",
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{
"exact_snippets": "HER2-negative",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "HR positive",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "breast cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "breast cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HER2-negative",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "HR positive",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "breast cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "breast cancer"
}
}
]
}
},
{
"identified_line": {
"line": "* Triple-negative breast cancer (TNBC)",
"criterions": [
{
"exact_snippets": "Triple-negative breast cancer (TNBC)",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "subtype",
"expected_value": "triple-negative"
}
}
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},
"logical_structure": {
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{
"exact_snippets": "Triple-negative breast cancer (TNBC)",
"criterion": "breast cancer",
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"requirement_type": "subtype",
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}
]
}
},
{
"identified_line": {
"line": "* Endometrial carcinoma",
"criterions": [
{
"exact_snippets": "Endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Squamous cell carcinoma [SqCC]",
"criterion": "squamous cell carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Adenocarcinoma [AC]",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
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"exact_snippets": "Non-small cell lung cancer",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Squamous cell carcinoma [SqCC]",
"criterion": "squamous cell carcinoma",
"requirement": {
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"expected_value": true
}
}
]
},
{
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"exact_snippets": "Non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
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"expected_value": true
}
},
{
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}
}
]
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}
},
{
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{
"exact_snippets": "Cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "gallbladder carcinoma",
"criterion": "gallbladder carcinoma",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"exact_snippets": "Cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
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"expected_value": true
}
},
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}
]
}
},
{
"identified_line": {
"line": "For Part E:",
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{
"exact_snippets": "Part E",
"criterion": "trial part",
"requirement": {
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"expected_value": "E"
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}
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},
"logical_structure": {
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"exact_snippets": "Part E",
"criterion": "trial part",
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}
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},
{
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"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",
"requirement": {
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"expected_value": [
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"cytologically"
]
}
},
{
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"criterion": "TNBC stage",
"requirement": {
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"metastatic"
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}
},
{
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"criterion": "CPS",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "N/A"
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}
}
]
},
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"cytologically"
]
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"unit": "N/A"
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"value": 10,
"unit": "N/A"
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}
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"unit": "N/A"
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"criterion": "breast cancer subtype",
"requirement": {
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"expected_value": "triple negative"
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"criterion": "residual disease",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "definitive surgery",
"criterion": "definitive surgery",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
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}
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}
},
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"criterion": "disease status",
"requirement": {
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}
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"criterion": "intolerance to SOC therapies",
"requirement": {
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"expected_value": true
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"requirement": {
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"expected_value": false
}
}
]
},
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"requirement": {
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"unit": "cycles"
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}
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}
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},
"else_criteria": null
}
},
{
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{
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}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"unit": "Years"
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},
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],
"exclusion_lines": [
{
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"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": [
{
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"operator": "<=",
"value": 3,
"unit": "years"
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}
},
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}
},
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"requirement": {
"requirement_type": "risk",
"expected_value": "negligible"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of another malignancy within 3 years before the first dose of study drug.",
"criterion": "history of another malignancy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
}
},
{
"not_criteria": {
"exact_snippets": "Exceptions are malignancies with a negligible risk of metastasis or death.",
"criterion": "malignancies with a negligible risk of metastasis or death",
"requirement": {
"requirement_type": "risk",
"expected_value": "negligible"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Any evidence of residual disease from a previously diagnosed malignancy.",
"criterion": "residual disease from a previously diagnosed malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "Exceptions are malignancies with a negligible risk of metastasis or death.",
"criterion": "malignancies with a negligible risk of metastasis or death",
"requirement": {
"requirement_type": "risk",
"expected_value": "negligible"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "previously treated brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "previously treated"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Known active central nervous system metastases",
"criterion": "central nervous system metastases",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
},
{
"exact_snippets": "previously treated brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "previously treated"
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment",
"criterion": "clinical stability after brain metastasis treatment",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* have no new or enlarging brain metastases",
"criterions": [
{
"exact_snippets": "no new or enlarging brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no new or enlarging brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "growth",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "no new or enlarging brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no new or enlarging brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "growth",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "duration off medication",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days",
"criterion": "corticosteroid use for brain metastases symptoms",
"requirement": {
"requirement_type": "duration off medication",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* Carcinomatous meningitis",
"criterions": [
{
"exact_snippets": "Carcinomatous meningitis",
"criterion": "carcinomatous meningitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Carcinomatous meningitis",
"criterion": "carcinomatous meningitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "Previous receipt of ... an agent targeting B7-H4",
"criterion": "agent targeting B7-H4",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Previous receipt of an MMAE-containing agent",
"criterion": "MMAE-containing agent",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "Previous receipt of ... an agent targeting B7-H4",
"criterion": "agent targeting B7-H4",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "Grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"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",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "Grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Corneal disease or injury requiring treatment or active monitoring",
"criterions": [
{
"exact_snippets": "Corneal disease or injury",
"criterion": "corneal disease or injury",
"requirement": {
"requirement_type": "treatment or active monitoring",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Corneal disease or injury",
"criterion": "corneal disease or injury",
"requirement": {
"requirement_type": "treatment or active monitoring",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
"criterion": "solid tumor type",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"unresectable",
"metastatic"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
"criterion": "solid tumor type",
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"requirement_type": "confirmation method",
"expected_value": "histologically"
}
},
{
"exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
"criterion": "solid tumor type",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"unresectable",
"metastatic"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
"criterion": "solid tumor type",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "cytologically"
}
},
{
"exact_snippets": "histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types",
"criterion": "solid tumor type",
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"requirement_type": "stage",
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"locally advanced",
"unresectable",
"metastatic"
]
}
}
]
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "histologically or cytologically confirmed",
"criterion": "confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "locally advanced unresectable or metastatic TNBC",
"criterion": "TNBC stage",
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"requirement_type": "stage",
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"metastatic"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "status",
"expected_value": "0"
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "status",
"expected_value": "1"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}