RecruitingPhase 1Phase 2NCT06244771

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

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

Sponsor

Frontier Medicines Corporation

Enrollment

403 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor Solid Tumor, Adult Unresectable Solid Tumor Advanced Solid Tumors With KRAS G12C Mutations

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new targeted drug called FMC-376 in people with solid tumors that carry a specific genetic change called a KRAS G12C mutation — a mutation found in some lung, colon, and pancreatic cancers, among others. FMC-376 is designed to specifically block the faulty KRAS protein that drives these cancers. **You may be eligible if...** - You have an advanced or metastatic solid tumor confirmed to have the KRAS G12C mutation - You have already tried standard treatments that did not work, or standard treatment is not appropriate for your situation - Your general health is good enough (ECOG performance status 0 or 1) - Your blood, liver, and kidney tests are within acceptable ranges - You are not enrolled in another interventional clinical trial **You may NOT be eligible if...** - Cancer has spread to the fluid around your brain or spinal cord (leptomeningeal disease) - You have significant ongoing side effects from previous cancer treatments - You have a known allergy or sensitivity to FMC-376 - You have a serious medical condition that would interfere with study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFMC-376

Oral Capsule Daily

Locations(26)

University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center

La Jolla, California, United States

University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, United States

Northwest Cancer Centers

Dyer, Indiana, United States

The University of Kansas Cancer Center

Fairway, Kansas, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Community Clinical Trials

Kingwood, Texas, United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Macquarie University

Macquarie Park, New South Wales, Australia

Tasman Health Care

Southport, Queensland, Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

GenesisCare North Adelaide

North Adelaide, South Australia, Australia

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do, Suwon-si, South Korea

View Full Details on ClinicalTrials.gov

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NCT06244771

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