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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllFrontier Medicines Corporation
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate) * 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 * For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis 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 * For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (โ‰ฅ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.
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What it tests

  • FMC-376
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Where

26 sites
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
La Jolla, United States
University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center
Orange, United States
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
Florida Cancer Specialists and Research Institute
Lake Mary, United States
Northwest Cancer Centers
Dyer, United States
The University of Kansas Cancer Center
Fairway, United States
Dana-Farber Cancer Institute
Boston, United States
Karmanos Cancer Institute
Detroit, United States

โ€ฆand 18 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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