RecruitingPhase 3NCT07252232

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Sponsor

Revolution Medicines, Inc.

Enrollment

500 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Resected Pancreatic Adenocarcinoma

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called daraxonrasib (RMC-6236) as a maintenance therapy after surgery in patients whose pancreatic cancer has been surgically removed. The drug targets the RAS protein, which drives cancer growth in most pancreatic cancers, with the goal of preventing the cancer from coming back. **You may be eligible if...** - You are 18 or older - You have confirmed pancreatic ductal adenocarcinoma that was completely removed by surgery - There is no sign of cancer coming back or spreading - You have already received multi-agent chemotherapy as part of your care (before or after surgery) - You completed your most recent treatment within the past 12 weeks - You are able to swallow oral medications - Your organ function meets study requirements **You may NOT be eligible if...** - You have previously received a RAS-targeted therapy - You have a condition that affects your ability to absorb oral medications - You had major surgery within 28 days of starting the study - You are unable or unwilling to comply with required study visits or procedures 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

DRUGdaraxonrasib

oral tablets

Locations(60)

Mayo Clinic

Phoenix, 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

University of California, Los Angeles

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

University of California, San Francisco

San Francisco, California, United States

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, United States

Hartford Healthcare

Hartford, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Florida Cancer Specialists

St. Petersburg, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Community Health Network

Indianapolis, Indiana, United States

University of Kansas Medical Center Research Institute, Inc.

Lawrence, Kansas, United States

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center

New York, New York, United States

Columbia University Medical Center

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

Taylor Cancer Research Center

Maumee, Ohio, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - DFW

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - Northeast Texas

Longview, Texas, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

CRLCC Eugene Marquis

Rennes, Cedex, France

Hôpital Paul Brousse

Villejuif, Val-De- Marne, France

Institut Gustave Roussy

Villejuif, Val-de-Marne, France

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IEO - Instituto Europeo di Oncologia

Milan, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, Italy

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital East

Chiba, Japan

Kyoto University Hospital

Kyoto, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Pan American Oncology Trials, LLC

San Juan, Puerto Rico

Dong-A University Hospital

Busan, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Vall d'Hebron - VHIO

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre

Birmingham, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London

London, United Kingdom

Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07252232

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