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Clinical Trials in Australia / NCT06244771
Recruiting Phase 1/2

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

NCT06244771 · tracked via the Priya Life Science Australia tracker
Sponsor
Frontier Medicines Corporation
Phase
Phase 1/2
Started
2024-02-12
Last updated
2026-03-18

Condition(s) studied

Advanced Solid Tumors With KRAS G12C MutationsSolid Tumor, AdultUnresectable Solid TumorMetastatic Solid TumorNon Small Cell Lung CancerColorectal CancerKRAS G12CPancreatic Cancer

Investigational drug(s) / intervention(s)

FMC-376

FMC-376: Oral Capsule Daily

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (26)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244771 on ClinicalTrials.gov ↗ ← All trials in Australia