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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrontier Medicines Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FMC-376

Treatment groups

403 Participants
are divided into 1 treatment group

Sponsors and collaborators