An Open-Label, Phase I/II 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

Study Identifier:
FMC-376-CL101
CT.gov Identifier:
NCT06244771
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

To evaluate the safety, tolerability, PK/PD and anti-tumor activity of FMC-376.

objectives include establishing doses, based on incidence of DLTs, identifying SAEs/AEs and changes in ECG parameters, characterizing the PK profile and evaluating the clinical activity of FMC-376 via RECIST v1.1

FMC-376 target engagement and changes in expression of RAS pathway genes will be evaluated

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
  • Gene Mutations
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: FMC-376
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Eligibility criteria include histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumors with KRAS G12C mutations, ECOG 0-1 and adequate hematologic, hepatic and renal function. Participants with stable treated brain metastases may be eligible,
    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
    • participants with leptomeningeal disease or carcinomatous meningitis are not eligible

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Gene Mutations
    Pancreas
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Gene Mutations
    Pancreas