Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
NCT ID: NCT06040541
Last Updated: 2025-08-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
604 participants
INTERVENTIONAL
2023-09-07
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
NCT06128551
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
NCT05379985
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT07349537
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
NCT03592641
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
NCT06445062
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RMC-9805 monotherapy arm
Dose exploration and dose expansion
RMC-9805
Oral Tablets
RMC-9805 plus RMC-6236 combination arm
Dose exploration and dose expansion
RMC-9805
Oral Tablets
RMC-6236
Oral Tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RMC-9805
Oral Tablets
RMC-6236
Oral Tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
* ECOG performance status 0 or 1
* Adequate organ function
Exclusion Criteria
* Known or suspected leptomeningeal or active brain metastases or spinal cord compression
* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
* Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Revolution Medicines, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Revolution Medicines, Inc.
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Smilow Cancer Hospital (Yale University)
New Haven, Connecticut, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Lee Moffitt Cancer Center
Tampa, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
START
San Antonio, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Weller C, Burnett GL, Jiang L, Chakraborty S, Zhang D, Vita NA, Dilly J, Kim E, Maldonato B, Seamon K, Eilerts DF, Milin A, Marquez A, Spradlin J, Helland C, Gould A, Ziv TB, Dinh P, Steele SL, Wang Z, Mu Y, Chugh S, Feng H, Hennessey C, Wang J, Roth J, Rees M, Ronan M, Wolpin BM, Hahn WC, Holderfield M, Wang Z, Koltun ES, Singh M, Gill AL, Smith JAM, Aguirre AJ, Jiang J, Knox JE, Wildes D. A neomorphic protein interface catalyzes covalent inhibition of RASG12D aspartic acid in tumors. Science. 2025 Jul 24;389(6758):eads0239. doi: 10.1126/science.ads0239. Epub 2025 Jul 24.
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
Review additional registry numbers or institutional identifiers associated with this trial.
RMC-9805-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.