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
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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 534 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Revolution Medicines, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 53 sites (Duarte, California and 52 other locations) |
| Trial ID | NCT06128551 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
- City of Hope — Duarte, California, United States (Withdrawn)
- UC IRVINE Health — Orange, California, United States (Recruiting)
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
- Stanford Cancer Institute — Stanford, California, United States (Recruiting)
- University of Colorado Cancer Center — Aurora, Colorado, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Cancer — Detroit, Michigan, United States (Withdrawn)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
- Sarah Cannon Research Institue — Nashville, Tennessee, United States (Recruiting)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Completed)
- MD Anderson — Houston, Texas, United States (Recruiting)
- NEXT Dallas — Irving, Texas, United States (Recruiting)
- NEXT Oncology San Antonio — San Antonio, Texas, United States (Recruiting)
- START Texas — San Antonio, Texas, United States (Recruiting)
- NEXT Oncology Virginia — Fairfax, Virginia, United States (Recruiting)
- West Cancer Institute — Angers, France (Recruiting)
- Institut Bergonie — Bordeaux, France (Recruiting)
- Hospital Louise Pradel — Bron, France (Recruiting)
- Oscar Lambret Center of Lillle — Lille, France (Recruiting)
- Centre Leon Berard — Lyon, France (Recruiting)
- Cancer Institute of Montpellier — Montpellier, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Institute of Cancer of Strasbourg — Strasbourg, France (Withdrawn)
- Universitäts Klinikum Köln — Cologne, Germany (Recruiting)
- Klinikum Esslingen GmbH — Esslingen am Neckar, Germany (Recruiting)
- Krankenhaus Bethanien Moers — Moers, Germany (Recruiting)
- Klinkum Nurnberg Paracelsus Medical Unviersity — Nuremberg, Germany (Recruiting)
- Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche — Ancona, Italy (Recruiting)
- Centro Di Riferimento Oncologico — Aviano, Italy (Recruiting)
- Institute Romagnolo per lo Studio Tumori — Meldola, Italy (Recruiting)
- Niguarda Cancer Center — Milan, Italy (Recruiting)
- Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" — Naples, Italy (Recruiting)
- San Luigi Hospital — Orbassano, Italy (Recruiting)
- AUSL Romagna - S.M. delle Croci Hospital — Ravenna, Italy (Recruiting)
- Netherlands Cancer Institute Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
- Pan American Center for Oncology Trials — San Juan, Puerto Rico (Recruiting)
- START Barcelona - Hospital HM Nou Delfos — Barcelona, Spain (Recruiting)
- Institut Catala d'Oncologia Hospital — Barcelona, Spain (Recruiting)
- University Clinic of Navarra — Madrid, Spain (Recruiting)
- Fundacion MD Anderson Cancer Center — Madrid, Spain (Recruiting)
- START Madrid — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- NEXT Oncology - Quirónsalud Madrid University Hospital — Madrid, Spain (Recruiting)
- University Clinic of Navarra — Pamplona, Spain (Recruiting)
+3 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Revolution Medicines, Inc.
- Email: medinfo@revmed.com
- Phone: 1-844-2-REVMED
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.