Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

  • STATUS
    Recruiting
  • End date
    Sep 11, 2023
  • participants needed
    740
  • sponsor
    Mirati Therapeutics Inc.
Updated on 11 March 2022
cancer
treatment regimen
KRAS
metastasis
pembrolizumab
cetuximab
primary cancer
solid tumour
solid tumor
solid neoplasm
ki-ras

Summary

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

Description

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

Details
Condition Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
Treatment Cetuximab, Pembrolizumab, Afatinib, MRTX849
Clinical Study IdentifierNCT03785249
SponsorMirati Therapeutics Inc.
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
Unresectable or metastatic disease
Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
Adequate organ function

Exclusion Criteria

History of intestinal disease or major gastric surgery or inability to swallow oral medications
Other active cancer
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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