RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 * What medical issues/symptoms do participants experience when taking NKT5097

Official Title

A Phase 1, 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

Quick Facts

Study Start:2025-06-30
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07029399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written informed consent
  2. * Advanced unresectable or metastatic solid tumor
  3. * Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
  4. * Measurable or evaluable disease (Part 1 \& 2 only)
  5. * Eighteen years of age or older
  6. * ECOG status of 0 or 1
  7. * Adequate organ function
  8. * Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
  9. * 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
  10. * Able to swallow oral meds
  11. * Willing to provide tumor tissue
  1. * Advanced solid tumor that is a candidate for curative treatment
  2. * 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
  3. * Not recovered from the effects of prior anticancer therapy
  4. * Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
  5. * Known active CNS metastases and/or carcinomatous meningitis
  6. * Active interstitial lung disease requiring treatment
  7. * History of uveitis, retinopathy, or other clinically significant retinal disease
  8. * Major surgery within 30 days of administration of first dose
  9. * Active uncontrolled infectious disease
  10. * Significant liver disease (Child Pugh class B or C)

Contacts and Locations

Study Locations (Sites)

South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229
United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, 84119
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: NiKang Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • CCNE1
  • cyclin E1
  • triple negative breast cancer
  • TNBC
  • estrogen receptor positive
  • HER2-
  • breast cancer
  • advanced solid tumors
  • post CDK4/6i
  • HER2 expression

Additional Relevant MeSH Terms

  • HR+ Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
  • CCNE1 Amplified Advanced Solid Tumors
  • HR+ HER2- Breast Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Uterine Carcinosarcoma