Recruiting

Phase 1

Phase 2

RAS(ON) InhibitorsStudy of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Sponsor:

Revolution Medicines, Inc.

Code:

NCT06445062

Conditions

Colorectal Cancer

CRC

Pancreatic Ductal Adenocarcinoma

PDAC

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RMC-6236

mFOLFOX6 regimen

bevacizumab

mFOLFIRINOX regimen

cetuximab

Study Details

Brief summary:

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.

The current subprotocols include the following:

Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens

Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens

Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel

Conditions

Colorectal Cancer

CRC

Pancreatic Ductal Adenocarcinoma

PDAC

Gastrointestinal Cancer

Study ID

NCT06445062

Start date

May 24, 2024

Status verified date

Jul, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All Patients (unless otherwise noted):

≥ 18 years of age
ECOG PS is 0 to 1
Adequate organ function as outlined by the study
Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)
Presence of RAS G12D mutation (Subprotocol D, E, F)

Exclusion Criteria:

All Patients:

Primary central nervous system (CNS) tumors
Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
Major surgery within 28 days of first dose

Other inclusion/exclusion criteria may apply.

Study Design

Enrollment

1130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC

RMC-6236 (QD) and Bevacizumab with 5-fluorouracil-based regimens

experimental: Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC

RMC-6236 (QD) and Cetuximab with or without mFOLFOX6

experimental: Subprotocol C: metastatic PDAC

RMC-6236 (QD) and Gemcitabine with Nab-paclitaxel

experimental: Subprotocol D: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC

RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Bevacizumab with 5-fluorouracil- based regimens

experimental: Subprotocol E: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC

RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Cetuximab with or without mFOLFOX6

experimental: Subprotocol F: RAS G12D-mutated metastatic PDAC

RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Gemcitabine with Nab-paclitaxel

Interventions

RMC-6236

Oral tablet

mFOLFOX6 regimen

IV infusion

bevacizumab

IV infusion

mFOLFIRINOX regimen

IV infusion

cetuximab

IV infusion

gemcitabine

IV infusion

nab-paclitaxel

IV infusion

RMC-9805

Oral Tablet

Primary outcome measure

Adverse events [ Time Frame: Up to 3 years ]
Dose limiting toxicities [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Revolution Medicines

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

Locations

Ironwood Cancer and Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Research Department

480-398-7671 research@ironwoodcrc.com

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

855-776-0015 mayocliniccancerstudies@mayo.edu

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Andrea House

480-323-1364 ahouse@honorhealth.com

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Andrea Galfo

858-822-4500 agalfo@health.com

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Naomi Geier

310-423-4693 naomi.geier@cshs.org

UCLA Hematology/Oncology- Santa Monica

Recruiting

Los Angeles, California, United States, 90404

Contacts

Jenna Davis

(310) 633-8400 jldavis@mednet.ucla.edu

University of Colorado Hospital-Anschutz Cancer Pavilion

Recruiting

Aurora, Colorado, United States, 88045

Contacts

Emily Harper

(303) 724-9407 Emily.harper@cuanschutz.edu

Yale-New Haven Hospital-Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Stefanie Diaz

475-227-1088 Stefanie.Diaz@yale.edu

Kwasi Boateng

203-314-7948 Kwasi.Boateng@yale.edu

Mayo Clinic Cancer Center

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

855-776-0015 mayocliniccancerstudies@mayo.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Nilufar Aliyeva

813.745.4436 Nilufar.Aliyeva@moffitt.org

The University of Kansas Clinical Research Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

913-945-7552 CTNurseNav@kumc.edu

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Colleen Apostol

410-614-3644 giclinicaltrials@jhmi.edu

Joann Santmyer

410-614-3644 giclinicaltrials@jhmi.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Aparna Parikh

(617) 724-4000 Aparna.Parikh@MGH.HARVARD.EDU

Bennett Caughey

(617) 724-4000 bcaughey1@mgb.org

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Charlotte Healy

617-632-5728 charlotte_healy@dfci.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

855-776-0015 mayocliniccancerstudies@mayo.edu

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Ashley Servais

4029552691 aservais@nebraskacancer.com

Evan Roberts

4023344773 eroberts@nebraskacancer.com

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Mahdi Hassan

402-559-1947 mhassan@unmc.edu

Monica Davis

402-559-9466 mondavis@unmc.edu

Atlantic Health System

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Salome Geene

973-971-6373 salome.geene@atlantichelath.org

Tracey Hilden

973-971-7889 tracey.hilden@atlantichealth.org

Northwell Health / RJ Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Deeksha Kaura

516-734-8906 GITrialReferral@northwell.edu

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Memorial Sloan Kettering Cancer Center Main Campus

Recruiting

New York, New York, United States, 10065

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Brooke Currier

919-668-1861 gi-oncology-cru@dm.duke.edu

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

513-584-7698 cancer@uchealth.com

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Christina Caldwell

405-271-8001 Christina-Caldwell@ouhsc.edu

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jimar Hill

215 349 8245 Jimar.Hill@pennmedicine.upenn.edu

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Henry Atencio

713-798-3743 Henry.VillalobosAtencio@bcm.edu

Glenn Wilson

713-798-3468 ggwilson@bcm.edu

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

GIClinicalTrials@mdanderson.org

NEXT Oncology Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Idara Ukpong

972.893.8800 iukpong@nextoncology.com

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Susan Sharry

(801) 585-3453 (Susan.Sharry@hci.utah.edu)

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22314

Contacts

Karina Castillo

571.350.8758 Karina.CastilloGrady@usoncology.com

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Matt Sherman

206-606-6347 mfsherman@fredhutch.org

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

CRC
PDAC
RAS Mutation
KRAS G12X
Colorectal Cancer
Pancreatic Cancer
Pancreatic Ductal Carcinoma
KRAS Q61 Mutation
KRAS G12 Mutation
RAS Wild-type
RAS G12D Mutation

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 2026-07-29.