Active — Not RecruitingPhase 1/2

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

United States731 participantsStarted 2019-01-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation

Timeframe: 20 months

Evaluate the pharmacokinetics of MRTX849

Timeframe: 20 months

Evaluate clinical activity/efficacy of MRTX849

Timeframe: 20 months

Trial details

NCT IDNCT03785249

SponsorMirati Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

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