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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.