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Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

NCT07349537 · Revolution Medicines, Inc.
In plain English

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Official title
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
About this study
This is an open-label, multicenter, Phase 1/1b study of RMC-5127 in adults with advanced KRAS G12V-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: RMC-5127 monotherapy arm, RMC-5127 plus daraxonrasib combination arm, and RMC-5127 plus cetuximab combination arm. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Both parts of the monotherapy arm may include Food Effect Cohorts.
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.
Study design
Enrollment target: 574 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-08
Estimated completion: 2028-10
Last updated: 2026-02-04
Interventions
Drug: RMC-5127Drug: daraxonrasibDrug: cetuximab
Primary outcomes
  • Number of patients with adverse events (AEs) (Up to approximately 3 years)
  • Changes in vital signs (Up to approximately 3 years)
  • Changes in electrocardiogram (ECG) test values (Up to approximately 3 years)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines Study Director · contact · medinfo@revmed.com · 1-844-2-REVMED
All locations (5)
START MidwestRecruiting
Grand Rapids, Michigan, United States
NEXT - DallasRecruiting
Dallas, Texas, United States
NEXTRecruiting
San Antonio, Texas, United States
START - San AntonioRecruiting
San Antonio, Texas, United States
NEXT - VirginiaRecruiting
Fairfax, Virginia, United States
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors · TrialPath