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

NCT ID: NCT05162443

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Cancer Metastatic Cancer Malignant Neoplasm

Interventions

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adagrasib (MRTX849)

adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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California Pacific Medical Center

San Francisco, California, United States

Site Status

Providence Medical Group Santa Rosa - Cancer Center

Santa Rosa, California, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Piedmont Cancer Institute

Atlanta, Georgia, United States

Site Status

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status

Renown Health

Reno, Nevada, United States

Site Status

Lehigh Valley Cancer Institute

Allentown, Pennsylvania, United States

Site Status

Lumi Research

Kingwood, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Seattle Integrative Cancer Center

Renton, Washington, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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849-EAP-001

Identifier Type: OTHER

Identifier Source: secondary_id

CA239-0067

Identifier Type: -

Identifier Source: org_study_id

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