Recruiting

Phase 1

Phase 2

RMC-6236Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Sponsor:

Revolution Medicines, Inc.

Code:

NCT05379985

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-6236

Study Details

Brief summary:

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Advanced Solid Tumors

Study ID

NCT05379985

Start date

May 31, 2022

Status verified date

May, 2026

Completion date

Jul 26, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
Treatment naive or have received prior standard therapy appropriate for tumor type and stage
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Exclusion Criteria:

Primary central nervous system (CNS) tumors
Active, untreated brain metastases
Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Other inclusion/exclusion criteria may apply.

Study Design

Enrollment

754 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: RMC-6236

Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations.

Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, Melanoma, gynecological cancer or other solid tumors not previously specified).

RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)

Interventions

RMC-6236

Oral Tablets

Primary outcome measure

Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs [ Time Frame: up to 2.5 years ]
Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Revolution Medicines, Inc.

1-844-273-8633 medinfo@revmed.com

Locations

UC Irvine/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

UCLA

Recruiting

Santa Monica, California, United States, 90404

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Columbia University

Recruiting

New York, New York, United States, 10032

Christ Hospital Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Tennessee Oncology

Recruiting

Chattanooga, Tennessee, United States, 37404

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Next Oncology

Recruiting

San Antonio, Texas, United States, 78229

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Next Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

KRAS
Non-small Cell Lung Cancer
Lung Cancer
Colorectal Cancer
Colon Cancer
Metastatic Cancer
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
NSCLC
CRC
PDAC
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Processes
Thoracic Neoplasms
Antineoplastic Agents
Melanoma
Gynecological Cancers
RAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-05-15.