A Study Evaluating FMC-376 in Participants with KRAS G12C Mutated Solid Tumors

Purpose

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.

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1A: sequential; Phase 1B and Phase 2: parallel
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FMC-376 		Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
  • Drug: FMC-376
    Oral Capsule

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Clinical Trials Specialist
210-450-5798
goodwine@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Frontier Medicines Corporation

Study Contact

Medical Lead
+1 (650) 457-1005
clinicaltrials@frontiermeds.com