Evaluating RMC-6291 and RMC-6236 for Advanced KRAS G12C Mutant Solid Tumors

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

Phase1; Phase2 Interventional Revolution Medicines, Inc. · NCT06128551

This study is testing a new combination of drugs to see if they can safely help adults with advanced solid tumors that have a specific KRAS mutation.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment534 (estimated)
Ages18 Years and up
SexAll
SponsorRevolution Medicines, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations53 sites (Duarte, California and 52 other locations)
Trial IDNCT06128551 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1b study aims to assess the safety, tolerability, and pharmacokinetics of RMC-6291 in combination with RMC-6236 in adults with advanced KRAS G12C-mutated solid tumors. The study is divided into two parts: a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to evaluate preliminary antitumor activity. Participants will include those with non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma who have previously undergone treatment. The study seeks to provide insights into effective treatment options for this specific mutation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with KRAS G12C-mutated advanced or metastatic solid tumors that are not amenable to curative therapy.

Not a fit: Patients with primary central nervous system tumors or active brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new therapeutic option for patients with advanced KRAS G12C-mutant solid tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel combination approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 18 years of age
* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

  1. Phase 1b Dose Escalation: solid tumors, previously treated
  2. Phase 1b Dose Expansion and Phase 2:

  i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
* ECOG performance status 0 or 1
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

Where this trial is running

Duarte, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Non-Small Cell Lung CancerColorectal CancerPancreatic Ductal AdenocarcinomaRMC-6291RASKRASKRASG12CTargeted therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.