Study on FMC-376 for Patients with KRAS G12C Mutated Advanced Solid Tumors

Sponsor: Frontier Medicines Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06244771

Provider View

This clinical trial is testing a new drug, FMC-376, to see if it is safe and effective for patients with advanced solid tumors that have a specific genetic mutation called KRAS G12C. The study will be conducted in three phases to determine the best dose and evaluate the drug's effects.

Patient Parameters

Program Overview

The purpose of this study is to test a new medication called FMC-376 in patients who have advanced solid tumors with a specific genetic change known as the KRAS G12C mutation. The trial will be conducted in three parts: Phase 1A will focus on finding the right dose, Phase 1B will expand the number of participants to further test the dose, and Phase 2 will involve more participants to see how well the drug works. Different doses will be tested to find the most effective and safe amount for patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumors that cannot be surgically removed or have spread, and have the KRAS G12C mutation.
  • Have tried standard treatments but they did not work, or cannot tolerate them, or standard treatments are not suitable.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including kidney and liver function.
  • Agree not to participate in another clinical trial while taking the study drug.

Exclusion Criteria

  • Have cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease) or have carcinomatous meningitis.
  • Have significant side effects from previous cancer treatments.
  • Have known or suspected allergies to FMC-376 or any ingredients in the study drug.
  • Have a condition that affects how the body absorbs medication.
  • Have any illness or medical history that could affect safety, compliance with study requirements, or the ability to interpret study results.

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