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Recruiting Phase 1/2 NCT06244771

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

Phase 1/2 – combined early trial
Conditions: Advanced Solid Tumors With KRAS G12C Mutations Solid Tumor, Adult Unresectable Solid Tumor Metastatic Solid Tumor Non Small Cell Lung Cancer Colorectal Cancer KRAS G12C Pancreatic Cancer

Sponsor: Frontier Medicines Corporation

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Overview
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.
Who can participate
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
Locations 3
Australia (1)
Macquarie University
Macquarie Park , New South Wales
South Korea (1)
Seoul National University Hospital
Seoul , Jongno-gu
United States (1)
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.02.2024
Completion date
01.04.2028
Registry ID
NCT06244771
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.