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RECRUITING
NCT07029399
PHASE1

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Sponsor: NiKang Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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