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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05162443
Enrollment
Unknown
Registered
2021-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Malignant Neoplasm, Metastatic Cancer

Keywords

adagrasib, expanded access

Brief summary

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.

Interventions

DRUGadagrasib (MRTX849)

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

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026