A Study Evaluating FMC-376 in Participants with KRAS G12C Mutated Solid Tumors
Sponsor: Frontier Medicines Corporation
ClinicalTrials ID:NCT06244771
This trial assesses FMC-376, an oral capsule, in advanced solid tumors with KRAS G12C mutations. It includes Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Eligible participants must have progressed on prior therapy, have an ECOG status of 0 or 1, and possess adequate organ function. Participants must not join other interventional studies during this trial.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
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 meningitis
- Clinically significant toxicity resulting from prior cancer therapies
- Known or suspected hypersensitivity to FMC-376 or any components of the study drug
- Condition that would interfere with study drug absorption
- Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center | 92037 | La Jolla | California |
| University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | 94158 | San Francisco | California |
| Florida Cancer Specialists and Research Institute | 32746 | Lake Mary | Florida |
| Northwest Cancer Centers | 46311 | Dyer | Indiana |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute Oncology Partners | 37203 | Nashville | Tennessee |
| Community Clinical Trials | 77339 | Kingwood | Texas |
| South Texas Accelerated Research Therapeutics, LLC | 78229 | San Antonio | Texas |
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