Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma

May 1, 2026 updated by: Revolution Medicines, Inc.

Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib

This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

This EAP has been established to provide access to daraxonrasib to patients with previously treated metastatic pancreatic adenocarcinoma during the period before potential commercial availability. Patients may be eligible if they have progressed on, are intolerant of, or are no longer expected to benefit from available standard therapies, and if they are not able to enroll in a clinical trial of daraxonrasib due to ineligibility or lack of access. This EAP is intended to address an unmet medical need and is not designed to support clinical development objectives.

Daraxonrasib is an investigational, orally administered, RAS(ON) inhibitor administered as monotherapy. Daraxonrasib will be supplied by the Sponsor free of charge during the duration of treatment under this program.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

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

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

N/A

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 PDAC with metastatic disease.
  • Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.
  • At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.
  • Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.
  • Adequate bone marrow, renal, hepatic, and coagulation functions.
  • Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.
  • Able to take oral medications

Exclusion Criteria:

  • History of known central nervous system metastatic disease.
  • Concurrent systemic anticancer therapy.
  • Significant cardiovascular disease.
  • Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).
  • Active uncontrolled systemic infection.
  • Major surgery within 28 days before enrollment.
  • Additional inclusion and exclusion criteria may apply.

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?

Collaborators and Investigators

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

Sponsor

Revolution Medicines, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-6236-401

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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