Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

August 20, 2025 updated by: Bristol-Myers Squibb

Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation

The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • Santa Rosa, California, United States, 95403
        • Providence Medical Group Santa Rosa - Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Health
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Cancer Institute
    • Texas
      • Kingwood, Texas, United States, 77339
        • Lumi Research
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Renton, Washington, United States, 98057
        • Seattle Integrative Cancer Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
  • Confirmed presence of a KRASG12C mutation
  • Ineligible for an ongoing clinical trial of MRTX849
  • No available or not eligible for standard of care treatment
  • Adequate organ function
  • CNS Metastases (within set parameters) are allowed
  • ECOG performance status of ≤ 2

Exclusion Criteria:

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
  • Prior therapy targeting a KRAS G12C mutation
  • Other active cancer

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

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

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

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA239-0067
  • 849-EAP-001 (Other Identifier: Mirati Protocol ID)

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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