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

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.

Interventions

• FMC-376 · DRUG

  Oral Capsule Daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (26)

• 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, Australia · RECRUITING
• Tasman Health Care, Southport, Queensland, Australia · RECRUITING
• Icon Cancer Centre Kurralta Park, Kurralta Park, South Australia, Australia · RECRUITING
• GenesisCare North Adelaide, North Adelaide, South Australia, Australia · RECRUITING
• Eastern Health - Box Hill Hospital, Box Hill, Victoria, Australia · RECRUITING
• Linear Clinical Research Ltd, Nedlands, Western Australia, Australia · RECRUITING
• Seoul National University Hospital, Seoul, Jongno-gu, South Korea · RECRUITING
• Severance Hospital, Seoul, Seodaemun-gu, South Korea · RECRUITING
• Korea University Anam Hospital, Seoul, Seongbuk-gu, South Korea · RECRUITING
• Seoul National University Bundang Hospital, Gyeonggi-do, Seongnam-si, South Korea · RECRUITING
• The Catholic University of Korea, St. Vincent's Hospital, Gyeonggi-do, Suwon-si, South Korea · RECRUITING