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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

  • Protocol Number: 202506063
  • Principal Investigator: Fa'ak, Faisal
  • Cancer Types: Early Phase

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief 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). 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

Protocol Interventions

Drug: NKT5097 CDK2/CDK4 dual degrader, Drug: Fulvestrant, Drug: Letrozole