Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Sponsor: Mirati Therapeutics Inc.
ClinicalTrials ID:NCT03785249
This Phase 1/2 study assesses the safety, tolerability, pharmacokinetics, and clinical activity of MRTX849 in patients with advanced solid tumors with a KRAS G12C mutation. Eligible patients have unresectable or metastatic disease. Interventions include oral MRTX849, intravenous pembrolizumab and cetuximab, and oral afatinib, depending on cohort assignment.
Patient Parameters
| Parameter | Options |
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Program Overview
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
Description
This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
- Unresectable or metastatic disease
- Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
- Adequate organ function
Exclusion Criteria
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
- Other active cancer
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| Alaska Oncology and Hematology | 99508 | Anchorage | Alaska |
| Mayo Clinic Arizona - Phoenix Campus | 85054 | Phoenix | Arizona |
| Local Institution - 001-807 | 85258 | Scottsdale | Arizona |
| Local Institution - 001-873-A | 85704 | Tucson | Arizona |
| USOR - Arizona Oncology - Tucson - Rudasill | 85704 | Tucson | Arizona |
| Local Institution - 001-840-B | 90706 | Bellflower | California |
| Beverly Hills Cancer Center | 90211 | Beverly Hills | California |
| City of Hope - Duarte (Main Campus) | 91010 | Duarte | California |
| Local Institution - 001-850-K | 94568 | Dublin | California |
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