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A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
Sponsor: Kestrel Therapeutics, Inc.
Summary
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.
Official title: A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
545
Start Date
2026-04-21
Completion Date
2029-04
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
KST-6051
KST-6051 will be administered orally as a tablet.
Gemcitabine/nab-paclitaxel
Gemcitabine/nab-paclitaxel will be administered intravenously (IV).
Cetuximab
Cetuximab will be administered IV.
Pembrolizumab
Pembrolizumab will be administered IV.
mFOLFOX6
mFOLFOX6 will be administered IV.
FOLFIRI
FOLFIRI will be administered IV.
Pemetrexed
Pemetrexed will be administered IV.
Carboplatin
Carboplatin will be administered IV.
Locations (9)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mass General Brigham Cancer Institute at Massachusetts General Hospital
Boston, Massachusetts, United States
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States