A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors (NCT07029399)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (12 items).
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (18 Sites)
- City of Hope — Duarte, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Yale Cancer Center — New Haven, Connecticut
- SCRI Florida Cancer Specialists - Sarasota — Sarasota, Florida
- University of Iowa — Iowa City, Iowa
- Dana-Farber Cancer Institute — Boston, Massachusetts
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan
- Washington University — St Louis, Missouri
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada
- Cleveland Clinic — Cleveland, Ohio
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- University of Texas Southwestern Medical Center — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- South Texas Accelerated Research Therapeutics (START) San Antonio — San Antonio, Texas
- South Texas Accelerated Research Therapeutics (START) Mountain Region — West Valley City, Utah
- NEXT Virginia — Fairfax, Virginia
- West Virginia University — Morgantown, West Virginia
📞 Contact the Study Coordinator
Phone: (302) 596-8654
Email: clinicaltrials@nikangtx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All HR+ Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.