{
"info": {
"nct_id": "NCT05579366",
"official_title": "Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors",
"inclusion_criteria": "Part A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma.\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received 1 to 3 prior lines of therapy. Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was the last line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Participants must have known FRα status based on an FDA approved test. Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.\n* Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment.\n* A switch/change in regimen due solely to toxicity or participant preference (and not disease progression) is not considered a separate line of therapy.\n\nPart D:\n\nCohort D1 (Rina-S+carboplatin):\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2 (Rina-S+bevacizumab):\n\n* Participants must have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\nCohort D3 (Rina-S+pembrolizumab):\n\n* Endometrial cancer (any subtype excluding sarcoma).\n* Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n* Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalation only).\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion/exclusion may apply.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed metastatic or unresectable solid malignancy",
"criterion": "solid malignancy",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": [
"histologically",
"cytologically"
]
},
{
"requirement_type": "stage",
"expected_value": [
"metastatic",
"unresectable"
]
}
]
},
{
"exact_snippets": "ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "subtype",
"expected_value": [
"epithelial ovarian cancer",
"primary peritoneal cancer",
"fallopian tube cancer"
]
}
]
},
{
"exact_snippets": "endometrial cancer",
"criterion": "endometrial cancer",
"requirements": []
},
{
"exact_snippets": "non-small cell lung cancer (Part A)",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "part",
"expected_value": "A"
}
]
},
{
"exact_snippets": "EGFR-mutated NSCLC (Part B)",
"criterion": "EGFR-mutated NSCLC",
"requirements": [
{
"requirement_type": "mutation",
"expected_value": "EGFR"
},
{
"requirement_type": "part",
"expected_value": "B"
}
]
},
{
"exact_snippets": "breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A)",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "receptor status",
"expected_value": [
"hormone receptor positive",
"HER2-negative",
"triple-negative"
]
},
{
"requirement_type": "part",
"expected_value": "A"
}
]
},
{
"exact_snippets": "mesothelioma",
"criterion": "mesothelioma",
"requirements": []
}
]
},
{
"line": "* Previously received therapies known to confer clinical benefit.",
"criterions": [
{
"exact_snippets": "Previously received therapies known to confer clinical benefit.",
"criterion": "previous therapies",
"requirements": [
{
"requirement_type": "clinical benefit",
"expected_value": true
}
]
}
]
},
{
"line": "* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.",
"criterions": [
{
"exact_snippets": "Measurable disease per RECIST v1.1",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "measurement standard",
"expected_value": "RECIST v1.1"
}
]
},
{
"exact_snippets": "pleural mesothelioma ... mRECIST v1.1",
"criterion": "pleural mesothelioma measurable disease",
"requirements": [
{
"requirement_type": "measurement standard",
"expected_value": "mRECIST v1.1"
}
]
}
]
},
{
"line": "Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
},
{
"exact_snippets": "metastatic or unresectable",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"metastatic",
"unresectable"
]
}
]
},
{
"exact_snippets": "epithelial ovarian cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "epithelial ovarian cancer"
}
]
}
]
},
{
"line": "* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)",
"criterions": [
{
"exact_snippets": "High grade serous ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "type",
"expected_value": "high grade serous"
}
]
},
{
"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": "type",
"expected_value": "N/A"
}
]
},
{
"exact_snippets": "excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element",
"criterion": "cancer type exclusions",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"endometrioid",
"clear cell carcinomas",
"mucinous",
"low grade",
"sarcomatous",
"neuroendocrine element"
]
}
]
}
]
},
{
"line": "* Participants must have received 1 to 3 prior lines of therapy. Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was the last line of therapy.",
"criterions": [
{
"exact_snippets": "Participants must have received 1 to 3 prior lines of therapy.",
"criterion": "prior lines of therapy",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was the last line of therapy.",
"criterion": "prior lines of therapy with MIRV as last line",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
},
{
"requirement_type": "last line of therapy",
"expected_value": "mirvetuximab soravtansine (MIRV)"
}
]
}
]
},
{
"line": "* Participants must have platinum-resistant ovarian cancer.",
"criterions": [
{
"exact_snippets": "platinum-resistant ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "resistance",
"expected_value": "platinum"
}
]
}
]
},
{
"line": "* Participants must have received prior bevacizumab.",
"criterions": [
{
"exact_snippets": "Participants must have received prior bevacizumab.",
"criterion": "prior bevacizumab treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.",
"criterions": [
{
"exact_snippets": "known or suspected deleterious germline or somatic BRCA mutations",
"criterion": "BRCA mutations",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "achieved a complete or partial response to platinum-based chemotherapy",
"criterion": "response to platinum-based chemotherapy",
"requirements": [
{
"requirement_type": "response",
"expected_value": [
"complete",
"partial"
]
}
]
},
{
"exact_snippets": "must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment",
"criterion": "treatment with PARP inhibitor",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants must have known FRα status based on an FDA approved test. Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.",
"criterions": [
{
"exact_snippets": "Participants must have known FRα status based on an FDA approved test.",
"criterion": "FRα status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.",
"criterion": "FRα positive status",
"requirements": [
{
"requirement_type": "treatment history",
"expected_value": "previously received MIRV"
}
]
}
]
},
{
"line": "* Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment.",
"criterions": [
{
"exact_snippets": "absence of disease progression while on active treatment",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* A switch/change in regimen due solely to toxicity or participant preference (and not disease progression) is not considered a separate line of therapy.",
"criterions": [
{
"exact_snippets": "switch/change in regimen due solely to toxicity",
"criterion": "regimen change due to toxicity",
"requirements": [
{
"requirement_type": "cause",
"expected_value": "toxicity"
}
]
},
{
"exact_snippets": "switch/change in regimen due solely to ... participant preference",
"criterion": "regimen change due to participant preference",
"requirements": [
{
"requirement_type": "cause",
"expected_value": "participant preference"
}
]
},
{
"exact_snippets": "not considered a separate line of therapy",
"criterion": "separate line of therapy",
"requirements": [
{
"requirement_type": "consideration",
"expected_value": false
}
]
}
]
},
{
"line": "Cohort D1 (Rina-S+carboplatin):",
"criterions": [
{
"exact_snippets": "Cohort D1 (Rina-S+carboplatin)",
"criterion": "treatment cohort",
"requirements": [
{
"requirement_type": "name",
"expected_value": "Cohort D1"
},
{
"requirement_type": "treatment",
"expected_value": [
"Rina-S",
"carboplatin"
]
}
]
}
]
},
{
"line": "* Participants must have platinum-sensitive ovarian cancer.",
"criterions": [
{
"exact_snippets": "platinum-sensitive ovarian cancer",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "sensitivity",
"expected_value": "platinum-sensitive"
}
]
}
]
},
{
"line": "* Participants must have received 1 to 3 prior lines of therapy.",
"criterions": [
{
"exact_snippets": "received 1 to 3 prior lines of therapy",
"criterion": "prior lines of therapy",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "Cohort D2 (Rina-S+bevacizumab):",
"criterions": [
{
"exact_snippets": "Cohort D2 (Rina-S+bevacizumab)",
"criterion": "treatment cohort",
"requirements": [
{
"requirement_type": "cohort",
"expected_value": "D2"
},
{
"requirement_type": "treatment",
"expected_value": [
"Rina-S",
"bevacizumab"
]
}
]
}
]
},
{
"line": "* Participants must have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.",
"criterions": [
{
"exact_snippets": "platinum-refractory",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "platinum sensitivity",
"expected_value": "refractory"
}
]
},
{
"exact_snippets": "platinum-resistant",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "platinum sensitivity",
"expected_value": "resistant"
}
]
},
{
"exact_snippets": "platinum-sensitive",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "platinum sensitivity",
"expected_value": "sensitive"
}
]
}
]
},
{
"line": "* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.",
"criterions": [
{
"exact_snippets": "Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC)",
"criterion": "prior lines of therapy for platinum-resistant ovarian cancer",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "lines"
},
{
"operator": "<=",
"value": 3,
"unit": "lines"
}
]
}
}
]
},
{
"exact_snippets": "up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC)",
"criterion": "prior lines of therapy for platinum-sensitive ovarian cancer",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 4,
"unit": "lines"
}
]
}
}
]
},
{
"exact_snippets": "Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV",
"criterion": "prior treatments",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": [
"bevacizumab",
"PARP inhibitor",
"MIRV"
]
}
]
}
]
},
{
"line": "Cohort D3 (Rina-S+pembrolizumab):",
"criterions": [
{
"exact_snippets": "Cohort D3 (Rina-S+pembrolizumab)",
"criterion": "treatment cohort",
"requirements": [
{
"requirement_type": "name",
"expected_value": "Cohort D3"
},
{
"requirement_type": "treatment",
"expected_value": [
"Rina-S",
"pembrolizumab"
]
}
]
}
]
},
{
"line": "* Endometrial cancer (any subtype excluding sarcoma).",
"criterions": [
{
"exact_snippets": "Endometrial cancer (any subtype excluding sarcoma)",
"criterion": "endometrial cancer",
"requirements": [
{
"requirement_type": "subtype",
"expected_value": {
"operator": "!=",
"value": 1,
"unit": "sarcoma"
}
}
]
}
]
},
{
"line": "* Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.",
"criterions": [
{
"exact_snippets": "Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.",
"criterion": "prior platinum-based chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"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 (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.",
"criterions": [
{
"exact_snippets": "History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years",
"criterion": "history of non-infectious interstitial lung disease (ILD)/pneumonitis",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "steroids"
},
{
"requirement_type": "time frame",
"expected_value": "within the past 2 years"
}
]
},
{
"exact_snippets": "has current ILD/pneumonitis",
"criterion": "current ILD/pneumonitis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "suspected ILD/pneumonitis cannot be ruled out by imaging at screening",
"criterion": "suspected ILD/pneumonitis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "cannot be ruled out by imaging at screening"
}
]
}
]
},
{
"line": "* Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalation only).",
"criterions": [
{
"exact_snippets": "Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days",
"criterion": "use of CYP3A inhibitor",
"requirements": [
{
"requirement_type": "strength",
"expected_value": "strong"
},
{
"requirement_type": "time frame",
"expected_value": "within 14 days"
}
]
}
]
},
{
"line": "* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.",
"criterions": [
{
"exact_snippets": "Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.",
"criterion": "prior therapy",
"requirements": [
{
"requirement_type": "drug type",
"expected_value": "topoisomerase 1 inhibitor-based antibody drug conjugate"
}
]
}
]
},
{
"line": "Note: Other protocol-defined inclusion/exclusion may apply.",
"criterions": [
{
"exact_snippets": "Other protocol-defined inclusion/exclusion",
"criterion": "protocol-defined inclusion/exclusion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "Part A and B:",
"criterions": [
{
"exact_snippets": "Part A",
"criterion": "Part A",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Part B",
"criterion": "Part B",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Part C:",
"criterions": []
},
{
"line": "Part D:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}