🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07029399
Recruiting Phase 1

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

NCT07029399 · tracked via the Priya Life Science USA tracker
Sponsor
NiKang Therapeutics, Inc.
Phase
Phase 1
Started
2025-03-25
Last updated
2026-08-28

Condition(s) studied

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)CCNE1 Amplified Advanced Solid TumorsHR+ HER2- Breast Cancer

Investigational drug(s) / intervention(s)

NKT5097 CDK2/CDK4 dual degraderFulvestrantLetrozole

NKT5097 CDK2/CDK4 dual degrader: NKT5097 will be distributed in tablet form and dosed daily or twice a day

Fulvestrant: Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.

Letrozole: Letrozole will be administered orally once daily.

Study 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, 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
Sarah Cannon Research Institute at HealthONE Denver Colorado Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
SCRI Florida Cancer Specialists - Sarasota Sarasota Florida Recruiting
University of Iowa Iowa City Iowa Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest Grand Rapids Michigan Recruiting
Washington University St Louis Missouri Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
South Texas Accelerated Research Therapeutics (START) San Antonio San Antonio Texas Recruiting
South Texas Accelerated Research Therapeutics (START) Mountain Region West Valley City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
West Virginia University Morgantown West Virginia Recruiting

More NiKang Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029399 on ClinicalTrials.gov ↗ ← All trials in the USA