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

a study on Solid Tumor Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer KRAS G12C Pancreatic Cancer Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSF
Dates
study started
completion around

Description

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.

Official Title

An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors

Keywords

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, Neoplasms, FMC-376

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Frontier Medicines Corporation
ID
NCT06244771
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 403 study participants
Last Updated