PROSPER / FMC-376-CL101
PROSPER / FMC-376-CL101: A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Trial 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.
Receptor status / problem studied:
Inclusion criteria
1) Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation.
2) 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.
3) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
4) Adequate hematological, renal, and hepatic function.
5) Agrees not to participate in another interventional study while receiving study drug.
Exclusion criteria
1) Leptomeningeal disease or carcinomatous meningitis.
2) Clinically significant toxicity resulting from prior cancer therapies.
3) Known or suspected hypersensitivity to FMC-376 or any components of the study drug.
4) Condition that would interfere with study drug absorption.
5) Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data.
Trial Title
PROSPER / FMC-376-CL101
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I/II