Tests NKT5097 pill in adults with advanced solid tumors, including breast cancer
Tests a new pill, NKT5097, for adults with advanced breast cancer or solid tumors.
Plain-language title generated from the registry record
Registry title: A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Key facts
- Where
- Boston, Cleveland, Dallas, Denver, Duarte, Fairfax, Grand Rapids, Houston, Iowa City, La Jolla, Las Vegas, Morgantown, New Haven, Pittsburgh, San Antonio, Sarasota, St Louis, Washington D.C., and West Valley City, United StatesSee the 19 sites
- Phase
- Phase 1
Where in United States
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Sarah Cannon Research Institute at HealthONEDenver, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- NEXT VirginiaFairfax, United StatesTaking people
- South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- Comprehensive Cancer Centers of NevadaLas Vegas, United StatesTaking people
- West Virginia UniversityMorgantown, United StatesTaking people
- Yale Cancer CenterNew Haven, United StatesTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
- South Texas Accelerated Research Therapeutics | START San AntonioSan Antonio, United StatesTaking people
- SCRI Florida Cancer Specialists - SarasotaSarasota, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
- Georgetown University Medical CenterWashington D.C., United StatesTaking people
- South Texas Accelerated Research Therapeutics (START) Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NiKang Therapeutics, Inc.
- Trial code
- NCT07029399
- Record updated
- 5 November 2026
- Original description
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:Read full original descriptionShow less
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
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
Inclusion: 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: Not recovered from the effects of prior anticancer therapy; Major surgery within 30 days of administration of first dose; Should not have received any prior selective investigational inhibitors or degraders (Part 5 only); 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; Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months; Active interstitial lung disease requiring treatment; History of uveitis, retinopathy, or other clinically significant retinal disease; Active uncontrolled infectious disease; Significant liver disease (Child Pugh class B or C); Advanced solid tumor that is a candidate for curative treatment; Known active CNS metastases and/or carcinomatous meningitis.