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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
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
- NKT5097 CDK2/CDK4 dual degrader (drug)
- Fulvestrant (drug)
- Letrozole (drug)
Sponsor: NiKang Therapeutics, Inc. · Participants: 361 · Started: Mar 25, 2025
Contact the study team
- Sponsor Contact · Phone: 302-596-8654
Official record on ClinicalTrials.gov — NCT07029399
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.