RecruitingPhase 1NCT07029399

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

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

Sponsor

NiKang Therapeutics, Inc.

Enrollment

205 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Endometrial Cancer Triple Negative Breast Cancer(TNBC)HR+ Breast Cancer HR+/HER2- Breast Cancer Uterine Carcinosarcoma CCNE1 Amplified Advanced Solid Tumors

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new investigational drug called NKT5097 (taken by mouth) in adults with advanced or metastatic solid tumors that have not responded to standard treatments. **You may be eligible if:** - You are 18 or older - You have an advanced or metastatic solid tumor that has not responded to or is not tolerable with existing treatments - You have measurable disease on imaging - You are in good physical health (able to carry out daily activities) - Your organ function (blood, liver, kidney) is within acceptable ranges - You are able to swallow oral medications **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have active brain metastases - You have a serious autoimmune condition - You have had certain prior treatments that would interfere with this study - Your cancer is a primary brain tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07029399

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