RecruitingPhase 1

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

United States361 participantsStarted 2025-03-25

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose-limiting toxicities as Assessed by CTCAE

Timeframe: From enrollment through end of safety monitoring period of 28 days from first dose

Trial details

NCT IDNCT07029399

SponsorNiKang Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Sponsor Contact

302-596-8654 clinicaltrials@nikangtx.com

View on ClinicalTrials.gov More HR+ Breast Cancer trials