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

Study Name
	Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
ClinicalTrials.gov Identifier (if applicable)
	NCT05162443
Clinical Trial Category (check all that apply)
	Targeted Therapy
Study Center
Institution Name
	Multiple Sites
State
	– Please Select –
Country
	United States
Website
	https://clinicaltrials.gov/ct2/show/NCT05162443
List additional Institutions (include address, phone number, and website)
	Please see https://clinicaltrials.gov/ct2/show/NCT05162443 or contact Early Access Care (Mirati.ExpandedAccess@earlyaccesscare.com) if interested in participating or opening the EAP.
Study Contacts
Principal Investigator
	Multiple
P.I. Phone
	(475) 522-2200
P.I. Email
	Mirati.ExpandedAccess@earlyaccesscare.com
Study Coordinator
	Johanna Hancock
Study Coordinator Phone
	(475) 522-2200
Study Coordinator Email
	Mirati.ExpandedAccess@earlyaccesscare.com
OVERVIEW – in layman’s terms (150 words max)
	This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
Enrollment
	up to 100 patients
Study Start Date
	12/17/2021
Estimated Completion Date
	N/A: approved for marketing, last updated 5/19/23
Inclusion Criteria – Patients Must:
	Have histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor Have confirmed presence of a KRASG12C mutation Be ineligible for an ongoing clinical trial of MRTX849 No available or not eligible for standard of care treatment Have adequate organ function Have an ECOG performance status of ≤ 2
Exclusion Criteria – Patients Must NOT:
	Have a 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 Have received prior therapy targeting a KRAS G12C mutation Have an other active cancer