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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Sponsor: NiKang Therapeutics, Inc.
Summary
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097
Official title: A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2025-03-25
Completion Date
2027-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Locations (14)
UC San Diego Moores Cancer Center
La Jolla, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States