Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (RASolute 303)

September 30, 2026 updated by: Revolution Medicines, Inc.

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Revolution Medicines Study Director
  • Phone Number: 1-844-2-REVMED
  • Email: medinfo@revmed.com

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St. George Hospital
      • Randwick, New South Wales, Australia, 2031
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
  • Austria
      • Vienna, Austria, 1020
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven (Univ Ziekenhuis Leuven)
  • Brazil
      • São Paulo, Brazil, 09060-650
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034-000
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University - Dept. Oncology Clinical Research Program
  • Germany
      • München, Germany, 81377
        • Recruiting
        • Klinikum der Universitaet Muenchen Campus Grosshadern
  • Hong Kong
    • Sha Tin
      • Hong Kong, Sha Tin, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Tricase, Italy, 73039
        • Recruiting
        • Azienda Ospedaliera Card. G. Panico
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
  • Japan
      • Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • NHO Kyushu Cancer Center
        • Contact:
          • Terumasa Hisano
          • Phone Number: +81-92-541-3231
      • Kanagawa, Japan, 241-0815
        • Recruiting
        • Kanagawa Cancer Canter
        • Contact:
          • Makoto Ueno
          • Phone Number: +81-45-520-2222
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center - Tokyo
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Reiko Ashida
          • Phone Number: +81-73-447-2300
      • Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Tatsuya Ioka
          • Phone Number: +81-836-22-2111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center - East
        • Contact:
          • Masafumi Ikeda
          • Phone Number: +81-4-7133-1111
    • Tokyo
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital - Japan Foundation for Cancer Research
        • Contact:
          • Masato Ozaka
          • Phone Number: +81-3-3520-0111
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
      • Utrecht, Netherlands, 3543 AZ
  • Singapore
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
      • Singapore, Singapore, 217562
  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center - PPDS
    • Republic of Korea
      • Daegu, Republic of Korea, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28064
        • Recruiting
        • Hospital Universitario La Paz - PPDS
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100225, R.O.C
        • Recruiting
        • National Taiwan University Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital - Birmingham
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • NHS Cambridge of Addenbrooke Hospital
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • The Clatterbridge Cancer Centre
      • London, United Kingdom, W1G 6AD
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital - London
      • London, United Kingdom, WC1E 6AG
        • Recruiting
        • University College London Hospital
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Barts Hospital
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Active, not recruiting
        • Mayo Clinic - Scottsdale
      • Scottsdale, Arizona, United States, 85258
        • Active, not recruiting
        • Honor Health Research Institute
    • California
      • Los Angeles, California, United States, 90095
        • Active, not recruiting
        • University of California Los Angeles Health - Hematology/Oncology
      • San Francisco, California, United States, 94158
        • Active, not recruiting
        • University of California San Francisco
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • Mayo Clinic Cancer Center- Florida
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • H Lee Moffitt Cancer Center and Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic Cancer Center- Rochester
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Active, not recruiting
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Active, not recruiting
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • University of Cincinnati Cancer Center
      • Maumee, Ohio, United States, 43537
        • Active, not recruiting
        • Taylor Cancer Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Active, not recruiting
        • SCRI Oncology Partners
    • Texas
      • Dallas, Texas, United States, 95246
        • Active, not recruiting
        • SCRI - Texas Oncology Dallas
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Active, not recruiting
        • Huntsman Cancer Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Active, not recruiting
        • Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98101
        • Active, not recruiting
        • Virginia Mason Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 or cytologically confirmed pancreatic adenocarcinoma.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

Exclusion Criteria:

  • Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • Active or known history of untreated central nervous system metastatic disease.
  • 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: daraxonrasib

study drug
Drug: daraxonrasib

oral tablets
Experimental: Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

study drug in combination with chemotherapy
Drug: nab-paclitaxel

IV infusion

Drug: daraxonrasib

oral tablets

Drug: gemcitabine

intravenous (IV) infusion
Active Comparator: Arm C: gemcitabine and nab-paclitaxel

SOC chemotherapy
Drug: nab-paclitaxel

IV infusion

Drug: gemcitabine

intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to approximately 2 years

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years

OS is defined as the time from randomization until death from any cause.
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 2 years

Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.
Up to approximately 2 years
Duration of response (DOR)
Time Frame: Up to approximately 2 years

DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.
Up to approximately 2 years
Concentration of daraxonrasib in Arm A and B
Time Frame: Up to Cycle 5 Day 1 (each cycle is 28 days)

Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.
Up to Cycle 5 Day 1 (each cycle is 28 days)
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)
Time Frame: Up to approximately 2 years

EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden.
Up to approximately 2 years
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Up to approximately 2 years

EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning.
Up to approximately 2 years
Incidence of adverse events (AEs)
Time Frame: Up to approximately 2 years

Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Up to approximately 2 years
Changes in vital signs
Time Frame: Up to approximately 2 years

Number of patients with clinically significant changes in vital signs
Up to approximately 2 years
Changes in clinical laboratory test values
Time Frame: Up to approximately 2 years

Number of patients with changes from baseline in clinical laboratory test values
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMC-6236-303

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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