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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Able to provide written informed consent
* Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only)
* Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only)
* Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only)
* Measurable or evaluable disease (Part 1, 2, \& 4 only).
* Measurable disease (Part 3 \& 5 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 during treatment and for 28 days after the last dose
* Able to swallow oral meds
* Willing to provide tumor tissue

Exclusion Criteria:

* Advanced solid tumor that is a candidate for curative treatment
* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
* Not recovered from the effects of prior anticancer therapy
* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
* Known active CNS metastases and/or carcinomatous meningitis
* Active interstitial lung disease requiring treatment
* History of uveitis, retinopathy, or other clinically significant retinal disease
* Major surgery within 30 days of administration of first dose
* Active uncontrolled infectious disease
* Significant liver disease (Child Pugh class B or C)
* Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)

About the study

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

What is being tested

Sponsor: NiKang Therapeutics, Inc. · Participants: 361 · Started: Mar 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07029399

Locations in the U.S.

CaliforniaCity of Hope, Duarte
UC San Diego Moores Cancer Center, La Jolla
ColoradoSarah Cannon Research Institute at HealthONE, Denver
ConnecticutYale Cancer Center, New Haven
FloridaSCRI Florida Cancer Specialists - Sarasota, Sarasota
IowaUniversity of Iowa, Iowa City
MassachusettsDana-Farber Cancer Institute, Boston
MichiganSouth Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids
MissouriWashington University, St Louis
NevadaComprehensive Cancer Centers of Nevada, Las Vegas
OhioCleveland Clinic, Cleveland
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TexasUniversity of Texas Southwestern Medical Center, Dallas
MD Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics (START) San Antonio, San Antonio
UtahSouth Texas Accelerated Research Therapeutics (START) Mountain Region, West Valley City
VirginiaNEXT Virginia, Fairfax
West VirginiaWest Virginia University, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.