Evaluating FMC-376 for advanced solid tumors with KRAS G12C mutations
An Open-Label, Phase 1/2 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
This study is testing a new drug called FMC-376 to see if it can help people with advanced solid tumors that have a specific KRAS G12C mutation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 403 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Frontier Medicines Corporation Industry-sponsored |
| Locations | 26 sites (La Jolla, California and 25 other locations) |
| Trial ID | NCT06244771 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of FMC-376 in patients with advanced solid tumors harboring KRAS G12C mutations. The study is structured in three parts: Phase 1A focuses on dose escalation, Phase 1B on dose expansion, and Phase 2 on cohort expansion to further evaluate the drug's effects. Participants will be closely monitored for responses and side effects throughout the trial. The goal is to identify optimal dosing and therapeutic benefits of FMC-376 in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors that have a confirmed KRAS G12C mutation and have either progressed on or are intolerant to prior therapies.
Not a fit: Patients with leptomeningeal disease, significant toxicity from previous treatments, or those with conditions affecting drug absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with KRAS G12C mutated solid tumors.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California and 25 other locations
- University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center — Orange, California, United States (Completed)
- University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (Recruiting)
- Florida Cancer Specialists and Research Institute — Lake Mary, Florida, United States (Completed)
- Northwest Cancer Centers — Dyer, Indiana, United States (Recruiting)
- The University of Kansas Cancer Center — Fairway, Kansas, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Community Clinical Trials — Kingwood, Texas, United States (Completed)
- South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States (Recruiting)
- UT Health San Antonio — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (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)
Study contacts
- Study coordinator: Medical Lead
- Email: clinicaltrials@frontiermeds.com
- Phone: +1 (650) 457-1005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.