NKT5097 for adults with advanced or metastatic solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first‑in‑human, open‑label Phase 1 study tests NKT5097, a novel oral dual protein degrader that targets CDK2 and CDK4, in adults with advanced or metastatic non‑CNS solid tumors with emphasis on breast cancer and CCNE1‑amplified tumors. Part 1 uses dose escalation across up to five dose levels to define safety and a recommended dose for expansion, Part 2 examines the effect of food on drug exposure, and Part 3 opens tumor‑specific expansion cohorts by backfilling selected dose levels. The trial will collect pharmacokinetics, pharmacodynamic biomarkers, tumor genomics, safety data, and preliminary anti‑tumor endpoints such as progression‑free survival and duration of response. The open‑label design means investigators and participants know the treatment being administered.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• SCRI Florida Cancer Specialists - Sarasota
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Sponsor Contact
• Email: clinicaltrials@nikangtx.com
• Phone: 302-596-8654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.