Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
NCT ID: NCT06128551
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
210 participants
INTERVENTIONAL
2023-11-14
2026-11-30
Brief Summary
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Detailed Description
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The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RMC-6291 and RMC-6236
Dose escalation and Dose expansion
Assigned interventions
Drug: RMC-6291 and RMC-6236 Oral tablets
Interventions
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Assigned interventions
Drug: RMC-6291 and RMC-6236 Oral tablets
Eligibility Criteria
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Inclusion Criteria
* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
1. Part 1. Dose Escalation: solid tumors, previously treated
2. Part 2. Dose Expansion:
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases \<2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
* ECOG performance status 0 or 1
* Adequate organ function
Exclusion Criteria
* 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
18 Years
125 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Revolution Medicines, Inc.
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
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City of Hope
Duarte, California, United States
UC IRVINE Health
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Institute
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Columbia University
New York, New York, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institue
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT Oncology San Antonio
San Antonio, Texas, United States
START Texas
San Antonio, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
West Cancer Institute
Angers, , France
Institut Bergonie
Bordeaux, , France
Hospital Louise Pradel
Bron, , France
Oscar Lambret Center of Lillle
Lille, , France
Centre Leon Berard
Lyon, , France
Cancer Institute of Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Institute of Cancer of Strasbourg
Strasbourg, , France
Universitäts Klinikum Köln
Cologne, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Krankenhaus Bethanien Moers
Moers, , Germany
Klinkum Nurnberg Paracelsus Medical Unviersity
Nuremberg, , Germany
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche
Ancona, , Italy
Centro Di Riferimento Oncologico
Aviano, , Italy
Institute Romagnolo per lo Studio Tumori
Meldola, , Italy
Niguarda Cancer Center
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Napoli, , Italy
San Luigi Hospital
Orbassano, , Italy
AUSL Romagna - S.M. delle Croci Hospital
Ravenna, , Italy
Netherlands Cancer Institute Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Pan American Center for Oncology Trials
San Juan, Puerto Rico, Puerto Rico
START Barcelona - Hospital HM Nou Delfos
Barcelona, , Spain
Institut Catala d'Oncologia Hospital
Barcelona, , Spain
University Clinic of Navarra
Madrid, , Spain
Fundacion MD Anderson Cancer Center
Madrid, , Spain
START Madrid
Madrid, , Spain
Hosptial Universitario 12 de Octubre
Madrid, , Spain
NEXT Oncology - Quirónsalud Madrid University Hospital
Madrid, , Spain
University Clinic of Navarra
Pamplona, , Spain
Hosptial Universitario Virgen Macarena
Seville, , Spain
La Fe University and Polytechnic Hospital
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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References
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Cregg J, Edwards AV, Chang S, Lee BJ, Knox JE, Tomlinson ACA, Marquez A, Liu Y, Freilich R, Aay N, Wang Y, Jiang L, Jiang J, Wang Z, Flagella M, Wildes D, Smith JAM, Singh M, Wang Z, Gill AL, Koltun ES. Discovery of Daraxonrasib (RMC-6236), a Potent and Orally Bioavailable RAS(ON) Multi-selective, Noncovalent Tri-complex Inhibitor for the Treatment of Patients with Multiple RAS-Addicted Cancers. J Med Chem. 2025 Mar 27;68(6):6064-6083. doi: 10.1021/acs.jmedchem.4c02314. Epub 2025 Mar 8.
Other Identifiers
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RMC-6291-101
Identifier Type: -
Identifier Source: org_study_id
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