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New pill takes aim at Hard-to-Treat cancers

NCT ID NCT06586957

Disease control Sponsor: NiKang Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental oral drug called NKT3964 in adults with advanced or metastatic solid tumors that have not responded to standard treatments. The drug works by degrading a protein (CDK2) that helps cancer cells grow. The study has two parts: first, finding a safe dose, and then testing how well that dose shrinks tumors in specific cancers like ovarian, endometrial, breast, gastric, and lung cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NKT3964 (an oral drug that degrades CDK2 protein to slow cancer growth)
What this could lead to
If successful, this could lead to a new oral treatment option for certain advanced solid tumors, especially those with CCNE1 amplification.
What could go wrong
This is an early Phase 1 trial with only 150 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. Dose Escalation: 1. Ovarian cancer 2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification) 3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification 4. Small cell lung cancer (SCLC) 5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative) 6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \[ET\]) 7. Other solid tumors with CCNE1 amplification Dose Expansion: Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4/6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \[ADC\]) in the metastatic setting.. Part 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease and with CCNE1 amplification. Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced/metastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test. Part 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug. * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

endometrial disorder endometrium neoplasm gastric cancer gastric carcinoma gastric neoplasm metastatic neoplasm Neoplasm Metastasis ovarian cancer ovarian carcinoma ovarian neoplasm progesterone-receptor positive breast cancer small cell lung carcinoma triple-negative breast carcinoma uterine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced endometrial carcinoma Advanced gastric carcinoma Advanced ovarian carcinoma Advanced solid tumor CCNE1 amplification Endometrial diseases Endometrial neoplasms Gastric cancer Hormone receptor negative breast carcinoma Human epidermal growth factor 2 negative carcinoma of breast Metastatic endometrial cancer Metastatic endometrial carcinoma Metastatic gastric cancer Metastatic gastric carcinoma Metastatic ovarian carcinoma Metastatic tumor Ovarian cancer Ovarian carcinoma Ovarian neoplasms Platinum-refractory ovarian carcinoma Platinum-resistant ovarian cancer Progesterone receptor-positive breast cancer Small cell lung cancer Small cell lung carcinoma Solid tumor Solid tumor, adult Triple negative breast neoplasms Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Cancer Institute

    RECRUITING

    Orlando, Florida, 32804, United States

  • Augusta University

    NOT_YET_RECRUITING

    Augusta, Georgia, 30912, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Florida Cancer Specialists & Research Institute

    TERMINATED

    Lake Mary, Florida, 32746, United States

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84145, United States

  • John Theurer Cancer Center at Hackensack UMC

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • NEXT Oncology

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI at HealthOne

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute (SCRI)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sidney Kimmell Cancer Center - Jefferson Health

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF

    WITHDRAWN

    San Francisco, California, 94158, United States

  • UPMC

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact Email: •••••@•••••

  • University of Arkansas Medical School

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California - Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Kansas

    WITHDRAWN

    Fairway, Kansas, 66205, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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