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

Bristol-Myers Squibb (BMS)

Status

Conditions: Metastatic Cancer; Advanced Cancer; Malignant Neoplasm

Treatments: Drug: adagrasib (MRTX849)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05162443

CA239-0067

849-EAP-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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