Phase 1/2 Study of MRTX849 for Patients with Cancer Having a KRAS G12C Mutation (KRYSTAL-1)
Sponsor: Mirati Therapeutics Inc.
ClinicalTrials ID:NCT03785249
This clinical trial is testing a new drug called MRTX849 (adagrasib) to see if it is safe and effective for patients with advanced cancers that have a specific genetic mutation known as KRAS G12C.
Patient Parameters
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Program Overview
The purpose of this study is to determine if the drug MRTX849 (adagrasib) is safe and can help treat advanced solid tumors in patients who have a KRAS G12C mutation. Researchers will look at how the drug affects the body, how it is processed, and its overall effectiveness in treating the cancer.
Description
This study is focused on evaluating a new treatment called MRTX849 (adagrasib) for patients with advanced solid tumors that have a specific mutation in the KRAS gene, known as G12C. MRTX849 is a small molecule drug taken by mouth that targets this mutation. The study will assess how safe the drug is, how well patients tolerate it, how the body absorbs and processes the drug, and its impact on the cancer. Participants will receive the drug and undergo various tests to monitor their health and the drug's effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of a solid tumor cancer with the KRAS G12C mutation.
- The cancer must be advanced, meaning it cannot be removed by surgery or has spread to other parts of the body.
- Standard treatments are not available, or the patient chooses not to undergo them. For some groups, this may include first-line treatment for non-small cell lung cancer (NSCLC).
- Must have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have a history of intestinal disease, major stomach surgery, or difficulty swallowing pills.
- Have another active cancer.
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