A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Phase 1/2 – combined early trial
Conditions:
Advanced Solid Tumors With KRAS G12C Mutations
Solid Tumor, Adult
Unresectable Solid Tumor
Metastatic Solid Tumor
Non Small Cell Lung Cancer
Colorectal Cancer
KRAS G12C
Pancreatic Cancer
Sponsor: Frontier Medicines Corporation
trial.available_in:
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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.
Who can participate
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