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Recruiting

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

NCT07349537 · Revolution Medicines, Inc.
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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: 2026-07-10
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 (9)
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Johns HopkinsRecruiting
Baltimore, Maryland, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, 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