A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
NCT ID: NCT06244771
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
403 participants
INTERVENTIONAL
2024-02-12
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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FMC-376
Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
FMC-376
Oral Capsule
Interventions
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FMC-376
Oral Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Frontier Medicines Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Lead
Role: STUDY_DIRECTOR
Frontier Medicines Corporation
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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International Health Care Center
Role: primary
Other Identifiers
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FMC-376-CL101
Identifier Type: -
Identifier Source: org_study_id
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