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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: NiKang Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07029399

Registry updated: 2026-08-28
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Description

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

Interventions

  • NKT5097 CDK2/CDK4 dual degrader (Drug)
    NKT5097 will be distributed in tablet form and dosed daily or twice a day
  • Fulvestrant (Drug)
    Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.
  • Letrozole (Drug)
    Letrozole will be administered orally once daily.

Eligibility criteria

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 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)

Conditions

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

Locations

  • City of Hope — Duarte, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
  • Yale Cancer Center — New Haven, Connecticut, United States
  • SCRI Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States
  • University of Iowa — Iowa City, Iowa, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States
  • Washington University — St Louis, Missouri, United States
  • Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • University of Texas Southwestern Medical Center — Dallas, Texas, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • South Texas Accelerated Research Therapeutics (START) San Antonio — San Antonio, Texas, United States
  • South Texas Accelerated Research Therapeutics (START) Mountain Region — West Valley City, Utah, United States
  • NEXT Virginia — Fairfax, Virginia, United States
  • West Virginia University — Morgantown, West Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record