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

NCT06244771 · Frontier Medicines Corporation
In plain English

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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
About this study
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
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
Study design
Enrollment target: 403 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-12
Estimated completion: 2028-04
Last updated: 2026-03-18
Interventions
Drug: FMC-376
Primary outcomes
  • Dose Limiting Toxicities (Up to 21 Days)
  • Adverse Events (AEs) (Approximately 24 Months)
Sponsor
Frontier Medicines Corporation · industry
Contacts & investigators
ContactMedical Lead · contact · clinicaltrials@frontiermeds.com · +1 (650) 457-1005
InvestigatorMedical Lead · study_director, Frontier Medicines Corporation
All locations (26)
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer CenterRecruiting
La Jolla, California, United States
University of California Irvine (UCI) - Chao Family Comprehensive Cancer CenterCompleted
Orange, California, United States
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterRecruiting
San Francisco, California, United States
Florida Cancer Specialists and Research InstituteCompleted
Lake Mary, Florida, United States
Northwest Cancer CentersRecruiting
Dyer, Indiana, United States
The University of Kansas Cancer CenterRecruiting
Fairway, Kansas, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Community Clinical TrialsCompleted
Kingwood, Texas, United States
South Texas Accelerated Research Therapeutics, LLCRecruiting
San Antonio, Texas, United States
UT Health San AntonioRecruiting
San Antonio, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Macquarie UniversityRecruiting
Macquarie Park, New South Wales, Australia
Tasman Health CareRecruiting
Southport, Queensland, Australia
Icon Cancer Centre Kurralta ParkRecruiting
Kurralta Park, South Australia, Australia
GenesisCare North AdelaideRecruiting
North Adelaide, South Australia, Australia
Eastern Health - Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Linear Clinical Research LtdRecruiting
Nedlands, Western Australia, Australia
Seoul National University HospitalRecruiting
Seoul, Jongno-gu, South Korea
Severance HospitalRecruiting
Seoul, Seodaemun-gu, South Korea
Korea University Anam HospitalRecruiting
Seoul, Seongbuk-gu, South Korea
Seoul National University Bundang HospitalRecruiting
Gyeonggi-do, Seongnam-si, South Korea
The Catholic University of Korea, St. Vincent's HospitalRecruiting
Gyeonggi-do, Suwon-si, South Korea
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors · TrialPath