Status:
ACTIVE_NOT_RECRUITING
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
- Other active cancer
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT03785249
Start Date
January 15 2019
End Date
December 31 2026
Last Update
September 30 2025
Active Locations (222)
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1
Local Institution - 001-826
Birmingham, Alabama, United States, 35294
2
Local Institution - 001-965
Anchorage, Alaska, United States, 99508
3
Local Institution - 001-821
Phoenix, Arizona, United States, 85054
4
Local Institution - 001-873-A
Tucson, Arizona, United States, 85704