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(17)

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Hartford Healthcare

Hartford, Connecticut, 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

Baltimore, Maryland, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Pan American Oncology Trials, LLC

San Juan, Puerto Rico, Puerto Rico

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre

Birmingham, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07252232

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