{
"info": {
"nct_id": "NCT05029882",
"official_title": "A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors",
"inclusion_criteria": "* Diagnosis of malignant solid tumor (World Health Organization [WHO] criteria).\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.\n* For Part 2 only - advanced non-squamous squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:\n\n * Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR NSCLC (Part 2i) and squamous NSCLC (Part 2iii).\n * Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).\n * Must have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.\n* For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on\n\n * If applicable, an immune checkpoint inhibitor.\n * If applicable, appropriate available therapies, including HER2-directed therapies.\n\nParticipants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible.\n\n* For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:\n\n * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).\n * Oxaliplatin.\n * Irinotecan.\n * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).\n * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).\n * If applicable, targeted therapy\n * Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102) or Regorafenib treated participants are eligible.\n* For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.\n\nFor Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options.\n\n* Intolerant to the standard treatment are eligible\n* For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on:\n\n * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)\n * Oxaliplatin\n * Irinotecan\n * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab)\n * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept)\n * If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Laboratory values meeting the criteria outlined in the protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan..\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol.\n* For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosis of malignant solid tumor (World Health Organization [WHO] criteria).",
"criterions": [
{
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"criterion": "malignant solid tumor",
"requirement": {
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"expected_value": true
}
},
{
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"expected_value": "World Health Organization [WHO]"
}
}
]
},
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}
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"criterions": [
{
"exact_snippets": "Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "evaluation criteria",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"
}
}
]
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"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"
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}
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"line": "* For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.",
"criterions": [
{
"exact_snippets": "advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC)",
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"requirement": {
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"expected_value": [
"advanced solid tumors",
"non-small cell lung cancer (NSCLC)",
"head and neck squamous cell carcinoma (HNSCC)",
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"colorectal cancer (CRC)",
"renal cell carcinoma (RCC)"
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}
},
{
"exact_snippets": "who have progressed on all standard of care therapy",
"criterion": "progression on standard of care therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
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},
{
"exact_snippets": "are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit",
"criterion": "amenability to surgical resection or other approved therapeutic options",
"requirement": {
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"expected_value": false
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"logical_structure": {
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{
"and_criteria": [
{
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"criterion": "cancer type",
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"advanced solid tumors",
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}
},
{
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{
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"advanced",
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}
},
{
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"and_criteria": [
{
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},
{
"exact_snippets": "For Part 2 only",
"criterion": "trial part",
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"operator": "<=",
"value": 2,
"unit": "lines"
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}
},
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"expected_value": "advanced"
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},
{
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"criterion": "surgical resection",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "not amenable to ... other approved therapeutic options that have demonstrated clinical benefit",
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"expected_value": false
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}
]
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"and_criteria": [
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"unit": "lines"
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"expected_value": false
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"expected_value": false
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}
]
}
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"identified_line": {
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"criterions": [
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"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "immune checkpoint inhibitor",
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"expected_value": true
}
},
"then_criteria": null,
"else_criteria": null
}
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"identified_line": {
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]
}
}
]
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}
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"else_criteria": null
}
},
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"expected_value": false
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]
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},
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{
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},
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},
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"expected_value": false
}
},
{
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"requirement": {
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"expected_value": false
}
}
]
},
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{
"and_criteria": [
{
"and_criteria": [
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"and_criteria": [
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}
}
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}
}
]
}
]
}
},
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"identified_line": {
"line": "* A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).",
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{
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"expected_value": true
}
}
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"expected_value": true
}
}
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}
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"identified_line": {
"line": "* Oxaliplatin.",
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{
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"expected_value": true
}
}
]
},
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"exact_snippets": "Oxaliplatin.",
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}
}
]
}
},
{
"identified_line": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Irinotecan.",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).",
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"expected_value": true
}
}
]
},
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"else_criteria": null
}
},
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}
},
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"criterions": [
{
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"criterion": "eligibility for standard therapy",
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"expected_value": false
}
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{
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"expected_value": false
}
},
{
"exact_snippets": "Prior trifluridine/tipiracil (TAS-102) ... treated participants are eligible",
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"requirement": {
"requirement_type": "treatment history",
"expected_value": true
}
},
{
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"expected_value": true
}
}
]
},
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"criterion": "eligibility for standard therapy",
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"requirement_type": "eligibility",
"expected_value": false
}
},
{
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"requirement": {
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"expected_value": false
}
}
]
},
{
"exact_snippets": "Prior trifluridine/tipiracil (TAS-102) ... treated participants are eligible",
"criterion": "prior treatment with trifluridine/tipiracil (TAS-102)",
"requirement": {
"requirement_type": "treatment history",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... Regorafenib treated participants are eligible",
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options.",
"criterions": [
{
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},
{
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"requirement": {
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"expected_value": "advanced"
}
},
{
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"criterion": "MET mutations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mutations in the tyrosine kinase domain",
"criterion": "MET mutations in the tyrosine kinase domain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mutations in ... the juxtamembrane region",
"criterion": "MET mutations in the juxtamembrane region",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mutations in ... the extracellular domain",
"criterion": "MET mutations in the extracellular domain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not amenable to surgical resection",
"criterion": "surgical resection",
"requirement": {
"requirement_type": "amenability",
"expected_value": false
}
},
{
"exact_snippets": "disease progression after at least one prior systemic therapy",
"criterion": "disease progression after systemic therapy",
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "therapy"
}
}
},
{
"exact_snippets": "no satisfactory alternative treatment options",
"criterion": "alternative treatment options",
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"requirement_type": "satisfaction",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "advanced histologically or cytologically confirmed solid tumors",
"criterion": "solid tumors",
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}
},
{
"exact_snippets": "advanced histologically or cytologically confirmed solid tumors",
"criterion": "solid tumors",
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"requirement_type": "stage",
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}
},
{
"exact_snippets": "solid tumors harboring MET mutations",
"criterion": "MET mutations",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
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"criterion": "MET mutations in the tyrosine kinase domain",
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"expected_value": true
}
},
{
"exact_snippets": "mutations in ... the juxtamembrane region",
"criterion": "MET mutations in the juxtamembrane region",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mutations in ... the extracellular domain",
"criterion": "MET mutations in the extracellular domain",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "not amenable to surgical resection",
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"expected_value": false
}
},
{
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{
"exact_snippets": "disease progression after at least one prior systemic therapy",
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"operator": ">=",
"value": 1,
"unit": "therapy"
}
}
},
{
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}
]
}
]
}
},
{
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{
"exact_snippets": "Intolerant to the standard treatment",
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"expected_value": true
}
}
]
},
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{
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
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"criterion": "advanced CRC",
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}
},
{
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"criterion": "mutation",
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"expected_value": false
}
},
{
"exact_snippets": "are not dMMR+/MSI-H",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"criterion": "Part 7 (CRC combination)",
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"requirement_type": "participation",
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}
},
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{
"exact_snippets": "history of advanced histopathologically or cytologically confirmed CRC",
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}
},
{
"exact_snippets": "does not harbor the mutation",
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"expected_value": false
}
},
{
"exact_snippets": "are not dMMR+/MSI-H",
"criterion": "dMMR+/MSI-H",
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"expected_value": false
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)",
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Oxaliplatin",
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{
"exact_snippets": "Oxaliplatin",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Oxaliplatin",
"criterion": "oxaliplatin",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Irinotecan",
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{
"exact_snippets": "Irinotecan",
"criterion": "irinotecan",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Irinotecan",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "anti-EGFR (including, but not limited to cetuximab or panitumumab)",
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"requirement_type": "applicability",
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}
}
]
},
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"requirement_type": "applicability",
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}
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
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{
"exact_snippets": "anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept)",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"condition": {
"exact_snippets": "If applicable",
"criterion": "applicability",
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"requirement_type": "applicability",
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}
},
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"requirement_type": "presence",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
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{
"exact_snippets": "targeted therapy Participants",
"criterion": "targeted therapy",
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}
},
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"expected_value": false
}
},
{
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"criterion": "standard therapy",
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"requirement_type": "tolerance",
"expected_value": false
}
},
{
"exact_snippets": "Participants treated previously with TAS-102 or regorafenib are not eligible",
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"requirement_type": "eligibility",
"expected_value": false
}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "targeted therapy Participants",
"criterion": "targeted therapy",
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"expected_value": true
}
},
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"expected_value": false
}
},
{
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"criterion": "standard therapy",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
}
]
}
]
},
"then_criteria": {
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"requirement_type": "eligibility",
"expected_value": false
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Laboratory values meeting the criteria outlined in the protocol.",
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{
"exact_snippets": "Laboratory values meeting the criteria outlined in the protocol.",
"criterion": "laboratory values",
"requirement": {
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"expected_value": "meeting the criteria outlined in the protocol"
}
}
]
},
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{
"exact_snippets": "Laboratory values meeting the criteria outlined in the protocol.",
"criterion": "laboratory values",
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"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",
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"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).",
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"exact_snippets": "Platinum-based chemotherapy doublet",
"criterion": "chemotherapy regimen",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based doublet"
}
},
{
"exact_snippets": "tyrosine kinase inhibitor(s) (TKI[s])",
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"requirement": {
"requirement_type": "type",
"expected_value": "tyrosine kinase inhibitor(s)"
}
},
{
"exact_snippets": "non-squamous mutEGFR NSCLC",
"criterion": "cancer type",
"requirement": {
"requirement_type": "subtype",
"expected_value": "non-squamous mutEGFR NSCLC"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Platinum-based chemotherapy doublet",
"criterion": "chemotherapy regimen",
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}
},
{
"exact_snippets": "tyrosine kinase inhibitor(s) (TKI[s])",
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"requirement": {
"requirement_type": "type",
"expected_value": "tyrosine kinase inhibitor(s)"
}
}
]
},
{
"exact_snippets": "non-squamous mutEGFR NSCLC",
"criterion": "cancer type",
"requirement": {
"requirement_type": "subtype",
"expected_value": "non-squamous mutEGFR NSCLC"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan..",
"criterions": [
{
"exact_snippets": "History of interstitial lung disease (ILD)",
"criterion": "interstitial lung disease (ILD)",
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"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "pneumonitis that required treatment with systemic steroids",
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"expected_value": true
}
},
{
"exact_snippets": "any evidence of active ILD",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "on screening chest CT scan",
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}
}
]
},
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"not_criteria": {
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"requirement_type": "history",
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}
}
},
{
"and_criteria": [
{
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},
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"or_criteria": [
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"not_criteria": {
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}
}
},
{
"not_criteria": {
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"requirement_type": "screening chest CT scan",
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}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "History of idiopathic pulmonary fibrosis",
"criterion": "idiopathic pulmonary fibrosis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... organizing pneumonia",
"criterion": "organizing pneumonia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... bronchiolitis obliterans",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... drug-induced pneumonitis",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... idiopathic pneumonitis",
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"requirement_type": "history",
"expected_value": true
}
}
]
},
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"expected_value": true
}
},
{
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"expected_value": true
}
},
{
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}
},
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},
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"exact_snippets": "History of ... idiopathic pneumonitis",
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}
}
]
}
},
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"expected_value": true
}
},
{
"exact_snippets": "History of clinically significant, intercurrent lung-specific illnesses",
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}
},
{
"exact_snippets": "History of clinically significant, intercurrent lung-specific illnesses",
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"requirement_type": "intercurrent",
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}
]
},
"logical_structure": {
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}
},
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]
},
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]
}
}
],
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"failed_inclusion": [
{
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"expected_value": true
}
},
{
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}
},
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}
},
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}
},
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"exact_snippets": "squamous NSCLC",
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}
}
]
},
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{
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"and_criteria": [
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"and_criteria": [
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}
},
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}
]
},
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}
}
]
},
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]
},
{
"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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}
},
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}
}
]
},
{
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}
}
]
},
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}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on",
"criterions": [
{
"exact_snippets": "advanced GEA",
"criterion": "advanced GEA",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen",
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}
},
{
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"criterion": "progression after treatment",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen",
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"requirement": {
"requirement_type": "minimum prior treatments",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "regimen"
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}
},
{
"exact_snippets": "not received more than 2 prior lines of cytotoxic chemotherapy regimens",
"criterion": "prior lines of cytotoxic chemotherapy regimens",
"requirement": {
"requirement_type": "maximum prior treatments",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "lines"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.",
"criterions": [
{
"exact_snippets": "advanced histologically or cytologically confirmed solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically or cytologically"
}
},
{
"exact_snippets": "advanced histologically or cytologically confirmed solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"exact_snippets": "characterized by MET amplification",
"criterion": "MET amplification",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not amenable to surgical resection",
"criterion": "surgical resection",
"requirement": {
"requirement_type": "amenability",
"expected_value": false
}
},
{
"exact_snippets": "disease progression after at least one prior systemic therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "after prior systemic therapy",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "therapy"
}
}
},
{
"exact_snippets": "no satisfactory alternative treatment options",
"criterion": "alternative treatment options",
"requirement": {
"requirement_type": "satisfactory",
"expected_value": false
}
},
{
"exact_snippets": "Participants who are intolerant to standard treatment are eligible",
"criterion": "intolerance to standard treatment",
"requirement": {
"requirement_type": "intolerance",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "0"
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "1"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.",
"criterions": [
{
"exact_snippets": "Prior TAS-102 ... treated participants are not eligible.",
"criterion": "TAS-102 treatment",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
},
{
"exact_snippets": "Prior ... regorafenib treated participants are not eligible.",
"criterion": "regorafenib treatment",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "For Part 7 only",
"criterion": "Part 7",
"requirement": {
"requirement_type": "participation",
"expected_value": true
}
},
"then_criteria": {
"or_criteria": [
{
"exact_snippets": "Prior TAS-102 ... treated participants are not eligible.",
"criterion": "TAS-102 treatment",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... regorafenib treated participants are not eligible.",
"criterion": "regorafenib treatment",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"else_criteria": null
}
}
],
"failed_miscellaneous": []
}