Evaluating FMC-376 for advanced solid tumors with KRAS G12C mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.

Where it's running

• University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
  La Jolla, California, United States Recruiting
• University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• 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

Study contacts

• Study coordinator: Medical Lead
• Email: clinicaltrials@frontiermeds.com
• Phone: +1 (650) 457-1005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.