A Phase I, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors

Study Identifier:
NKT5097-101
CT.gov Identifier:
NCT07029399
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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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).

To assess the safety, tolerability, PK, PD and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification.

The study aims to determine the recommended dose(s) for future expansion cohorts.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast
  • Breast Cancers
  • Solid Tumor
  • Ovarian
  • Endometrial
  • Uterine
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1 Dose Escalation
    • Read More
  • Drug: Drug: NKT5097 CDK2/CDK4 dual degrader
  • Drug: Experimental: Part 2 Food Effect
  • Drug: Experimental: Part 3 Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Able to provide written informed consent
    • * Advanced unresectable or metastatic solid tumor
    • * Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
    • * Measurable or evaluable disease (Part 1 \& 2 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)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast
    Breast Cancers
    Solid Tumor
    Ovarian
    Endometrial
    Uterine
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast
    Breast Cancers
    Solid Tumor
    Ovarian
    Endometrial
    Uterine
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast
    Breast Cancers
    Solid Tumor
    Ovarian
    Endometrial
    Uterine