Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
RASolute 304
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)
1 other identifier
interventional
500
9 countries
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pancreatic-cancer
Started Dec 2025
Typical duration for phase_3 pancreatic-cancer
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 26, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 10, 2030
July 31, 2026
June 1, 2026
3.4 years
November 13, 2025
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS) per Investigator
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 Outcomes (6)
Overall survival (OS)
Up to approximately 5 years
DFS per blinded independent central review (BICR)
Up to approximately 5 years
DFS Rate at 1 year and 2 years
Up to approximately 2 years
OS rate at 1 year and 2 years
Up to approximately 2 years
Safety and tolerability of daraxonrasib
Up to approximately 5 years
- +1 more secondary outcomes
Study Arms (2)
daraxonrasib
EXPERIMENTALstudy drug
SOC Observation
NO INTERVENTIONPatients randomized to the comparator control arm will receive SOC observation.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Mayo Clinic
Phoenix, Arizona, 85054, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles
Los Angeles, California, 90404, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228, United States
Hartford Healthcare
Hartford, Connecticut, 06103, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33701, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Community Health Network
Indianapolis, Indiana, 46250, United States
University of Kansas Medical Center Research Institute, Inc.
Lawrence, Kansas, 66045, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Northeast Texas
Longview, Texas, 75601, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 94112, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
CRLCC Eugene Marquis
Rennes, Cedex, 35042, France
Hôpital Paul Brousse
Villejuif, Val-De- Marne, 94804, France
Institut Gustave Roussy
Villejuif, Val-de-Marne, 94805, France
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IEO - Instituto Europeo di Oncologia
Milan, 20141, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134, Italy
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Pan American Oncology Trials, LLC
San Juan, 00909, Puerto Rico
Dong-A University Hospital
Busan, 49201, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
Birmingham, B15 2TH, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G22 0YN, United Kingdom
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
London, SW3 6JJ, United Kingdom
Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
London, W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 26, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
May 10, 2029
Study Completion (Estimated)
July 10, 2030
Last Updated
July 31, 2026
Record last verified: 2026-06