An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors
Frontier Medicines Corporation
Summary
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation * Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hematological, renal, and hepatic function * Agrees not to participate in another interventional study while receiving study drug Exclusion Criteria: * Leptomeningeal disease or carcinomatous m…
Interventions
- DrugFMC-376
Oral Capsule Daily
Locations (26)
- University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer CenterLa Jolla, California
- University of California Irvine (UCI) - Chao Family Comprehensive Cancer CenterOrange, California
- University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Florida Cancer Specialists and Research InstituteLake Mary, Florida
- Northwest Cancer CentersDyer, Indiana
- The University of Kansas Cancer CenterFairway, Kansas