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A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Sponsor: Frontier Medicines Corporation
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
403
Start Date
2024-02-12
Completion Date
2028-04
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
FMC-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