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A First-in-human Phase 1 Dose-escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally to adults with advanced or metastatic solid tumors with certain KRAS mutations.
This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and preliminary activity of orally administered KST-6051. The trial seeks to enroll adults with advanced or metastatic KRAS mutant solid tumors including but not limited to pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose cancers have progressed after prior therapy or in whom standard therapy was not tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051 will be given in subsequent groups of participants. Participants can stay in the trial as long as they benefit from the treatment and can tolerate it.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
April 1, 2026
Primary Completion Date
June 1, 2027
Completion Date
May 1, 2028
Last Updated
March 9, 2026
145
ESTIMATED participants
KST-6051
DRUG
Lead Sponsor
Kestrel Therapeutics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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