Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Sponsor: Revolution Medicines, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of patients with adverse events (AEs)
Time frame: Up to approximately 3 years
Changes in vital signs
Time frame: Up to approximately 3 years
Changes in electrocardiogram (ECG) test values
Time frame: Up to approximately 3 years
Changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Secondary Endpoints
Cmax concentrations of RMC-5127 and daraxonrasib
Tmax concentration of RMC-5127 and daraxonrasib
AUC concentrations of RMC-5127 and daraxonrasib
Eligibility Criteria
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy. * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage. * Measurable per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation). * Able to take oral medications. Exclusion Criteria: * Primary central nervous system (CNS) tumors * Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors). * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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