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

Last updated: August 27, 2026
Sponsor: NiKang Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Vaginal Cancer

Pelvic Cancer

Ovarian Cancer

Treatment

NKT5097 CDK2/CDK4 dual degrader

Fulvestrant

Letrozole

Clinical Study ID

NCT07029399
NKT5097-101
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 effectivecontraception and to refrain from sperm donation during treatment and for 28 daysafter the last dose

  • Able to swallow oral meds

  • Willing to provide tumor tissue

Exclusion

Exclusion Criteria:

  • Advanced solid tumor that is a candidate for curative treatment

  • History of another malignancy except for the following: adequately treated localbasal cell or squamous carcinoma of the skin, in situ cervical cancer, adequatelytreated papillary noninvasive bladder cancer, other adequately treated Stage I orStage 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)

Study Design

Total Participants: 361
Treatment Group(s): 3
Primary Treatment: NKT5097 CDK2/CDK4 dual degrader
Phase: 1
Study Start date:
March 25, 2025
Estimated Completion Date:
December 31, 2027

Study Description

This First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of NKT5097, a novel dual protein degrader of CDK2 and CDK4, is split into 3 Parts:

Part 1: Monotherapy Dose Escalation in selected advanced/metastatic non-CNS primary solid tumors will be enrolled based on a projected total of 5 dose levels

Part 2: Food Effect Analysis: Subjects with solid tumors (as noted in Part 1) will be enrolled (by backfilling selected dose cohorts) to evaluate the effect of dosing with food on NKT5097.

Part 3: Monotherapy Tumor-specific Expansion: Subjects may be enrolled (by backfilling selected dose cohorts) into each selected tumor-specific cohort. One or more of these cohorts may be opened at the discretion of the Sponsor in consultation with the DEC

Part 4: Combination Dose Escalation with ET in selected HR+/HER2- breast cancer will be enrolled based on a projected 2 dose levels

Part 5: Combination Dose Expansion with ET in HR+/HER2- breast cancer in one or more various cohorts

In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • SCRI Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Washington University

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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