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: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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.