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NCT06244771PHASE1, PHASE2Recruiting

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

Frontier Medicines Corporation

Start Date

2/12/2024

Completion Date

4/1/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

FMC-376

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

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

Locations

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

La Jolla, California 92037

United States

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

Orange, California 92868

United States

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

San Francisco, California 94158

United States

Florida Cancer Specialists and Research Institute

Lake Mary, Florida 32746

United States

Northwest Cancer Centers

Dyer, Indiana 46311

United States

The University of Kansas Cancer Center

Fairway, Kansas 66205

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Community Clinical Trials

Kingwood, Texas 77339

United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas 78229

United States

UT Health San Antonio

San Antonio, Texas 78229

United States

START Mountain Region

West Valley City, Utah 84119

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Macquarie University

Macquarie Park, New South Wales 2109

Australia

Tasman Health Care

Southport, Queensland 4215

Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia 5037

Australia

GenesisCare North Adelaide

North Adelaide, South Australia 5006

Australia

Eastern Health - Box Hill Hospital

Box Hill, Victoria 3128

Australia

Linear Clinical Research Ltd

Nedlands, Western Australia 6009

Australia

Seoul National University Hospital

Seoul, Jongno-gu 03080

South Korea

Severance Hospital

Seoul, Seodaemun-gu 03722

South Korea

Korea University Anam Hospital

Seoul, Seongbuk-gu 02841

South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si 13620

South Korea

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

Gyeonggi-do, Suwon-si 16247

South Korea