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A Study of NKT5097 for Advanced Solid Tumors and Breast Cancer

This study is testing a new drug called NKT5097 for adults with advanced or metastatic (spread to other parts of the body) solid tumors, including certain types of breast cancer (HR+ Breast Cancer, Triple Negative Breast Cancer, and HR+ HER2- Breast Cancer) and solid tumors with CCNE1 amplification. NKT5097 works by targeting specific proteins (CDK2 and CDK4) that can help cancer cells grow. Some participants will receive NKT5097 alone, while others will receive it with Fulvestrant or Letrozole, which are existing hormone therapies. The main goal is to see how safe NKT5097 is and what side effects participants experience. Researchers also want to find the best dose to use in future studies. You may be eligible if you have advanced cancer that hasn't responded to other treatments.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It aims to enroll up to 361 participants.
What's involved
NKT5097 will be taken as a tablet daily or twice daily. Fulvestrant is given as an injection, and Letrozole is taken orally once daily.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from enrollment through 28 days after your first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07029399

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
NiKang Therapeutics, Inc.
~361 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NKT5097 CDK2/CDK4 dual degraderFulvestrantLetrozole

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities as Assessed by CTCAE
Measured over From enrollment through end of safety monitoring period of 28 days from first dose

Conditions

HR+ Breast Cancer
Triple Negative Breast Cancer (TNBC)
CCNE1 Amplified Advanced Solid Tumors
HR+ HER2- Breast Cancer

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Breast CarcinomaHR+/HER2- Breast CancerSolid NeoplasmTriple-negative breast cancerG1/S-Specific Cyclin-E1

Where it's being run

18 sites across 15 states
Texas3
California2
Colorado1
Connecticut1
Florida1
Iowa1
Massachusetts1
Michigan1

Who to contact

Sponsor Contact
[email protected]
302-596-8654
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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)

What this trial measures

  • Incidence of dose-limiting toxicities as Assessed by CTCAEFrom enrollment through end of safety monitoring period of 28 days from first dose