Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304)

August 21, 2026 updated by: Revolution Medicines, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Revolution Medicines Study Director
  • Phone Number: 1-844-2-REVMED
  • Email: medinfo@revmed.com

Study Locations

  • France
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
    • Cedex
      • Rennes, Cedex, France, 35042
        • Recruiting
        • CRLCC Eugene Marquis
    • Val-De- Marne
      • Villejuif, Val-De- Marne, France, 94804
        • Recruiting
        • Hopital Paul Brousse
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Germany
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20141
        • Recruiting
        • IEO - Instituto Europeo di Oncologia
      • Padova, Italy, 35128
        • Recruiting
        • IOV - Istituto Oncologico Veneto IRCCS
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona s.r.l.
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
      • Tokyo, Japan, 135-8550
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Pan American Oncology Trials, LLC
        • Contact:
  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - VHIO
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Rocío Garcia Carbonero
          • Phone Number: 0034 913908003
      • Seville, Spain, 41013
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Estibaliz San Martín González
          • Phone Number: 2712 0034 948255400
          • Email: esgonzalez@unav.es
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
        • Contact:
      • Glasgow, United Kingdom, G22 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
        • Contact:
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
        • Contact:
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
      • Los Angeles, California, United States, 90404
        • Recruiting
        • University of California, Los Angeles
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Cancer at Cedars-Sinai Medical Center
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
    • Colorado
      • Lakewood, Colorado, United States, 80228
    • Connecticut
      • Hartford, Connecticut, United States, 06103
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
        • Contact:
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Study Coordinator
          • Phone Number: 727-216-1143
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Recruiting
        • University of Kansas Medical Center Research Institute, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
        • Contact:
        • Contact:
          • Mike Pishvaian
          • Phone Number: 202-660-6500
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute (DFCI)
        • Contact:
          • Phone Number: 617-632-3000
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Cancer Center
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10032
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
        • Contact:
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Scri Oncology Partners
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW
      • Houston, Texas, United States, 77030
      • Longview, Texas, United States, 75601
    • Utah
      • Salt Lake City, Utah, United States, 94112
        • Recruiting
        • University of Utah, Huntsman Cancer Institute
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
  • Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
  • Must have completed most recent treatment within the past 12 weeks.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Documented RAS mutation status.
  • Able to take oral medications.

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • Any conditions that may affect the ability to take or absorb study drug.
  • Major surgery within 28 days prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: daraxonrasib
study drug
Drug: daraxonrasib
oral tablets
No Intervention: SOC Observation
Patients randomized to the comparator control arm will receive SOC observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) per Investigator
Time Frame: Up to approximately 5 years
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from randomization until death from any cause.
Up to approximately 5 years
DFS per blinded independent central review (BICR)
Time Frame: Up to approximately 5 years
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR.
Up to approximately 5 years
DFS Rate at 1 year and 2 years
Time Frame: Up to approximately 2 years
DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.
Up to approximately 2 years
OS rate at 1 year and 2 years
Time Frame: Up to approximately 2 years
OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.
Up to approximately 2 years
Safety and tolerability of daraxonrasib
Time Frame: Up to approximately 5 years
Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.
Up to approximately 5 years
Pharmacokinetics (PK)
Time Frame: Up to Cycle 4 Day 1 (Day 85)
Predose concentration of daraxonrasib
Up to Cycle 4 Day 1 (Day 85)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revolution Medicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

May 10, 2029

Study Completion (Estimated)

July 10, 2030

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-6236-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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