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

Recruiting now · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06244771

Run by

Frontier Medicines Corporation

People needed

403

Starts

2024-02-12

Expected to finish

2028-04-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• The Catholic University of Korea, St. Vincent's Hospital — Gyeonggi-do, Suwon-si, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, Seongbuk-gu, South Korea (enrolling)
• Seoul National University Bundang Hospital — Gyeonggi-do, Seongnam-si, South Korea (enrolling)
• University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center — La Jolla, California, United States (enrolling)
• University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• Northwest Cancer Centers — Dyer, Indiana, United States (enrolling)
• The University of Kansas Cancer Center — Fairway, Kansas, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States (enrolling)
• UT Health San Antonio — San Antonio, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Macquarie University — Macquarie Park, New South Wales, Australia (enrolling)
• Tasman Health Care — Southport, Queensland, Australia (enrolling)
• Icon Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia (enrolling)
• GenesisCare North Adelaide — North Adelaide, South Australia, Australia (enrolling)
• Eastern Health - Box Hill Hospital — Box Hill, Victoria, Australia (enrolling)
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia (enrolling)
• Seoul National University Hospital — Seoul, Jongno-gu, South Korea (enrolling)
• Severance Hospital — Seoul, Seodaemun-gu, South Korea (enrolling)
• University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center — Orange, California, United States
• Community Clinical Trials — Kingwood, Texas, United States

Full record on ClinicalTrials.gov

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