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RECRUITINGPHASE1

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

NCT06040541•Revolution Medicines, Inc.

Summary

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
•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

•Primary central nervous system (CNS) tumors
•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)

Locations (17)

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

Key Dates

Start Date

September 7, 2023

Primary Completion Date

April 30, 2026

Completion Date

April 30, 2027

Last Updated

August 28, 2025

Enrollment

604

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Advanced Solid Tumors

Interventions

RMC-9805

DRUG

RMC-6236

DRUG

Contacts

Revolution Medicines, Inc.

CONTACT

1-844-2-REVMED medinfo@RevMed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Inclusion Criteria

Exclusion Criteria

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