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

Part of paid clinical trials in La Jolla, California.

Sponsor
Frontier Medicines Corporation
Study ID
NCT06244771
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Feb 12, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
403 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: FMC-376
    Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle

Primary Outcome Measure

Dose Limiting Toxicities [ Time Frame: Up to 21 Days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer CenterLa JollaCalifornia92037
Study Coordinator
858-822-5354
University of California Irvine (UCI) - Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Project Manager
418-969-0533
Florida Cancer Specialists and Research InstituteLake MaryFlorida32746-
Northwest Cancer CentersDyerIndiana46311
Study Coordinator
219-924-8178
The University of Kansas Cancer CenterFairwayKansas66205
Study Coordinator
913-945-7552
Dana-Farber Cancer InstituteBostonMassachusetts02215
Study Coordinator
877-338-7425
Karmanos Cancer InstituteDetroitMichigan48201
Study Coordinator
313-576-9816
University of PennsylvaniaPhiladelphiaPennsylvania19104
Program Manager
267-414-6179
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Study Coordinator
888-513-6613
Community Clinical TrialsKingwoodTexas77339-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229
Physician Referral Coordinator
210-593-5265
UT Health San AntonioSan AntonioTexas78229
Clinical Trials Specialist
210-450-5798
START Mountain RegionWest Valley CityUtah84119
Director, Clinical Operation
801-907-4770
Virginia Cancer SpecialistsFairfaxVirginia22031
Clinical Trials Nurse Navigator
703-636-1473

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