RecruitingPhase 1Phase 2NCT06445062

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

A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Sponsor

Revolution Medicines, Inc.

Enrollment

1,130 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma Gastrointestinal Cancer CRC PDAC

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests experimental drugs called RAS(ON) inhibitors in patients with gastrointestinal cancers — specifically pancreatic cancer and colorectal cancer — that carry specific RAS gene mutations. RAS mutations are common in these cancers and have been difficult to target until recently. **You may be eligible if...** - You are 18 or older in good general health (ECOG 0–1) - You have confirmed metastatic pancreatic cancer or metastatic colorectal cancer with a RAS mutation (especially KRAS G12D for some sub-studies) - Your organs are functioning adequately **You may NOT be eligible if...** - You have primary brain tumors - You have significant gastrointestinal problems that would affect how you absorb oral medication - You had major surgery within 28 days of starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRMC-6236

Oral tablet

DRUGmFOLFOX6 regimen

IV infusion

DRUGbevacizumab

IV infusion

DRUGmFOLFIRINOX regimen

IV infusion

DRUGcetuximab

IV infusion

DRUGgemcitabine

IV infusion

DRUGnab-paclitaxel

IV infusion

DRUGRMC-9805

Oral Tablet

Locations(32)

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA Hematology/Oncology- Santa Monica

Los Angeles, California, United States

University of Colorado Hospital-Anschutz Cancer Pavilion

Aurora, Colorado, United States

Yale-New Haven Hospital-Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic Cancer Center

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Kansas Clinical Research Center

Westwood, Kansas, United States

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Atlantic Health System

Morristown, New Jersey, United States

Northwell Health / RJ Zuckerberg Cancer Center

Lake Success, New York, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center Main Campus

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology Dallas

Irving, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06445062

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