Phase 1/2 Study of MRTX849 for Patients with Cancer Having a KRAS G12C Mutation (KRYSTAL-1)

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

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

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.

Locations

FACILITYZIPCITYSTATE
ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham35294BirminghamAlabama
Alaska Oncology and Hematology99508AnchorageAlaska
Mayo Clinic Arizona - Phoenix Campus85054PhoenixArizona
Local Institution - 001-80785258ScottsdaleArizona
Local Institution - 001-873-A85704TucsonArizona
USOR - Arizona Oncology - Tucson - Rudasill85704TucsonArizona
Local Institution - 001-840-B90706BellflowerCalifornia
Beverly Hills Cancer Center90211Beverly HillsCalifornia
City of Hope - Duarte (Main Campus)91010DuarteCalifornia
Local Institution - 001-850-K94568DublinCalifornia

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