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Study of NKT3964 for Advanced Solid Tumors

This study is testing a new oral drug called NKT3964 for adults with advanced or metastatic (spread to other parts of the body) solid tumors that have progressed on standard treatments. The study aims to find a safe and effective dose of NKT3964. Researchers will look at how many participants experience serious side effects (Dose Limiting Toxicity) within 28 days, and how many see their tumors shrink or disappear (Objective Response Rate) within one year. You might be eligible if you have certain advanced solid tumors like ovarian cancer, or specific types of breast cancer, especially if your tumor has certain genetic changes like CCNE1 amplification or HER2 status.

Study design
This study plans to enroll 150 participants. It is an interventional study, meaning participants will receive the study drug NKT3964.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure how many participants see their tumors shrink or disappear (Objective Response Rate) for up to 1 year.

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

NCT06586957

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
NiKang Therapeutics, Inc.
~150 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:NKT3964

At a glance

Recruiting sites
13 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicity (DLT) events
Measured over 28 Days
+1 more outcome measured

Conditions

Solid Tumor
Advanced Solid Tumor
Solid Tumor, Adult
Metastatic Tumor
Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Metastatic Ovarian Carcinoma
Endometrial Neoplasms
Endometrial Diseases
Metastatic Endometrial Cancer
Triple Negative Breast Cancer
Metastatic Endometrial Carcinoma
Advanced Endometrial Carcinoma
Advanced Ovarian Carcinoma
Gastric Cancer
Advanced Gastric Carcinoma
Metastatic Gastric Cancer
Metastatic Gastric Carcinoma
Small Cell Lung Cancer
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Platinum-resistant Ovarian Cancer
Platinum-refractory Ovarian Carcinoma
CCNE1 Amplification
Hormone Receptor Negative Breast Carcinoma
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Progesterone-receptor-positive Breast Cancer

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NCT06586957

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Cancer Institute

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Intermountain Health

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jerseystudy coordinator listed

    Recruiting

  • NEXT Oncology

    Austin, Texasstudy coordinator listed

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Have adequate organ function
Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception
Ability to swallow oral medications.
Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment

Exclusion

Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
History of another malignancy with exceptions
History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.
Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
Known active CNS metastases and/or carcinomatous meningitis
Active interstitial lung disease currently requiring treatment
History of uveitis, retinopathy or other clinically significant retinal disease
Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease
Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.
Known human immunodeficiency virus (HIV), active hepatitis B or C infection
Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader
Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder
Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1

What this trial measures

  • Number of Participants with Dose Limiting Toxicity (DLT) events28 Days

    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  • Objective Response Rate (ORR)1 Year

    ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as determined by the Investigator