Study on FMC-376 for Patients with KRAS G12C Mutated Advanced Solid Tumors
Sponsor: Frontier Medicines Corporation
ClinicalTrials ID:NCT06244771
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
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center | 92037 | La Jolla | California |
| University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | 94158 | San Francisco | California |
| Florida Cancer Specialists and Research Institute | 32746 | Lake Mary | Florida |
| Northwest Cancer Centers | 46311 | Dyer | Indiana |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute Oncology Partners | 37203 | Nashville | Tennessee |
| Community Clinical Trials | 77339 | Kingwood | Texas |
| South Texas Accelerated Research Therapeutics, LLC | 78229 | San Antonio | Texas |
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