A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors (PROSPER)

Frontier Medicines

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Solid Tumor, Adult

Unresectable Solid Tumor

KRAS G12C

Advanced Solid Tumors With KRAS G12C Mutations

Non Small Cell Lung Cancer

Metastatic Solid Tumor

Pancreatic Cancer

Colorectal Cancer

Treatments

Drug: FMC-376

Study type

Interventional

Funder types

Industry

Identifiers

NCT06244771

FMC-376-CL101

Details and patient eligibility

About

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.

Enrollment

403 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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