A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Start Date
3/25/2025
Completion Date
12/31/2027
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, for both monotherapy and in combination with ET * What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET
Detailed Description
This First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of NKT5097, a novel dual protein degrader of CDK2 and CDK4, is split into 3 Parts: Part 1: Monotherapy Dose Escalation in selected advanced/metastatic non-CNS primary solid tumors will be enrolled based on a projected total of 5 dose levels Part 2: Food Effect Analysis: Subjects with solid tumors (as noted in Part 1) will be enrolled (by backfilling selected dose cohorts) to evaluate the effect of dosing with food on NKT5097. Part 3: Monotherapy Tumor-specific Expansion: Subjects may be enrolled (by backfilling selected dose cohorts) into each selected tumor-specific cohort. One or more of these cohorts may be opened at the discretion of the Sponsor in consultation with the DEC Part 4: Combination Dose Escalation with ET in selected HR+/HER2- breast cancer will be enrolled based on a projected 2 dose levels Part 5: Combination Dose Expansion with ET in HR+/HER2- breast cancer in one or more various cohorts In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NKT5097 CDK2/CDK4 dual degrader
Fulvestrant
Letrozole
Conditions
Locations
City of Hope
Duarte, California 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Yale Cancer Center
New Haven, Connecticut 06520
United States
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232
United States
University of Iowa
Iowa City, Iowa 52242
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02115
United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan 49546
United States
Washington University
St Louis, Missouri 63110
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas 78229
United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah 84119
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
West Virginia University
Morgantown, West Virginia 26506
United States