Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1
- Status
- Recruiting
- Start
- 2026-01-08
- End
- 2028-10
- Enrollment
- 574
- Sites
- 9
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: RMC-5127. oral tablets
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: daraxonrasib. oral tablets
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: cetuximab. IV infusion
Arm · public domain (ClinicalTrials.gov) · T1
Arm A: RMC-5127 Monotherapy (experimental): Dose Escalation and Dose Expansion
Arm · public domain (ClinicalTrials.gov) · T1
Arm B: RMC-5127 + Daraxonrasib Combination (experimental): Dose Escalation and Dose Expansion
Arm · public domain (ClinicalTrials.gov) · T1
Arm C: RMC-5127 + Cetuximab Combination (experimental): Dose Escalation and Dose Expansion
Primary outcome · public domain (ClinicalTrials.gov) · T1
Number of patients with adverse events (AEs). Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5 Time frame: Up to approximately 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Changes in vital signs. Number of patients with changes from baseline in vital signs Time frame: Up to approximately 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Changes in electrocardiogram (ECG) test values. Number of patients with changes from baseline in ECG test values Time frame: Up to approximately 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Changes in clinical laboratory test values. Number of patients with changes from baseline in clinical laboratory test values Time frame: Up to approximately 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Limiting Toxicities. Number of patients with dose limiting toxicities Time frame: Up to 28 days.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Cmax concentrations of RMC-5127 and daraxonrasib. Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days).
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Tmax concentration of RMC-5127 and daraxonrasib. Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days).
Secondary outcome · public domain (ClinicalTrials.gov) · T1
AUC concentrations of RMC-5127 and daraxonrasib. Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days).
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Ratio of accumulation of RMC-5127. Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days).
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Half-Life of RMC-5127 and daraxonrasib. Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days).
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective Response Rate (ORR). Time frame: Up to approximately 3 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
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.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 574 participants (estimated).