RECRUITING

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

Description

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 MutationsSolid Tumor, AdultUnresectable Solid TumorMetastatic Solid TumorNon Small Cell Lung CancerColorectal CancerKRAS G12CPancreatic Cancer
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Related Conditions:

Advanced Solid Tumors with KRAS G12C MutationsSolid Tumor, AdultUnresectable Solid TumorMetastatic Solid TumorNon Small Cell Lung CancerColorectal CancerKRAS G12CPancreatic Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors with KRAS G12C Mutations
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

San Francisco

University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94158

Lake Mary

Florida Cancer Specialists and Research Institute, Lake Mary, Florida, United States, 32746

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Nashville

Sarah Cannon Research Institute Oncology Partners, Nashville, Tennessee, United States, 37203

Kingwood

Community Clinical Trials, Kingwood, Texas, United States, 77339

San Antonio

South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States, 78229

West Valley City

START Mountain Region, West Valley City, Utah, United States, 84119

Fairfax

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Frontier Medicines Corporation,

Andrew Krivoshik, MD, PhD, STUDY_DIRECTOR, Frontier Medicines Corporation

Study Record Dates

2028-04