Recruiting
Phase 1

RMC-9805

Sponsor:

Revolution Medicines, Inc.

Code:

NCT06040541

Conditions

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RMC-9805

RMC-6236

Study Details

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Advanced Solid Tumors

Study ID

NCT06040541

Start date

Sep 7, 2023

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Other inclusion/exclusion criteria may apply.

Study Design

Enrollment

604 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RMC-9805 monotherapy arm

Dose exploration and dose expansion

experimental: RMC-9805 plus RMC-6236 combination arm

Dose exploration and dose expansion

Interventions

RMC-9805

Oral Tablets

RMC-6236

Oral Tablets

Primary outcome measure

  • Adverse events [ Time Frame: Up to 3 years ]
  • Dose Limiting Toxicities [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Revolution Medicines, Inc.

1-844-2-REVMEDmedinfo@RevMed.com

Locations

University of California, Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Smilow Cancer Hospital (Yale University)

Recruiting

New Haven, Connecticut, United States, 06511

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Lee Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

NYU Langone

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Sarah Cannon Research Institute at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

University of Texas, MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

START

Recruiting

San Antonio, Texas, United States, 78229

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • KRAS G12D (ON)
  • NSCLC
  • CRC
  • PDAC
  • Non-small Cell Lung Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Metastatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Neoplasms
  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms
  • KRAS
  • Colonic Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-06-03.