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

Sponsor: Mirati Therapeutics Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05162443

Patient View

This Expanded Access Program provides adagrasib (MRTX849) to patients with advanced solid tumors with a KRAS G12C mutation. Eligible patients must have adequate organ function, ECOG ≤ 2, and no prior KRAS G12C-targeted therapy. Exclusions include certain gastrointestinal conditions and other active cancers. Adagrasib is taken orally twice daily.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

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