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
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: 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: 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 In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
205
NKT5097 will be distributed in tablet form and dosed daily or twice a day
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGSarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGSCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSouth Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSouth Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States
RECRUITING...and 2 more locations
Incidence of dose-limiting toxicities as Assessed by CTCAE
Time frame: From enrollment through end of safety monitoring period of 28 days from first dose
Incidence of adverse events (AEs) as defined by CTCAE Version 5
Time frame: From enrollment through end of treatment up to 2 years
Maximum concentration Cmax after a single dose and multiple doses
Time frame: Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) after a single dose and multiple doses from first dose through the last timepoint with quantifiable concentration (Tlast)
Time frame: Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)
Maximum concentration (Cmax) when dosed with and without food
Time frame: Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) when dosed with and without food from dosing through the last timepoint with quantifiable concentration (Tlast)
Time frame: Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days)
Time to maximum plasma concentration (Tmax) after a single dose and multiple doses
Time frame: Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Investigator-assessed ORR by RECIST v1.1
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Investigator-assessed PFS by RECIST v1.1
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Duration of Response (DOR)
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.