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
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
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: 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to provide written informed consent * Advanced unresectable or metastatic solid tumor * Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only) * Measurable or evaluable disease (Part 1 \& 2 only) * Eighteen years of age or older * ECOG status of 0 or 1 * Adequate organ function * Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol * Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation…
Interventions
- DrugNKT5097 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 CenterLa Jolla, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- SCRI Florida Cancer Specialists - SarasotaSarasota, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, Michigan