TerminatedPhase 1

Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

Stopped: The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.

United States7 participantsStarted 2021-07-28

Plain-language summary

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 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 (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer) * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function Exclusion Criteria: * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow * Other active cancer * Cardiac abnormalities

What they're measuring

Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation

Timeframe: 20 months

Evaluate Pharmacokinetics of the combination regimen

Timeframe: 20 months

Establish Maximum Tolerated Dose

Timeframe: 12 months

Trial details

NCT IDNCT04975256

SponsorMirati Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-02

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