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

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

Trial Details

NCT ID
NCT07029399
Phase
PHASE1
Sponsor
NiKang Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • NKT5097 CDK2/CDK4 dual degrader
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Denver, Colorado, United States|39.73915,-104.9847
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Able to provide written informed consent
  • Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only)
  • Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only)
  • Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only)

For full eligibility, visit ClinicalTrials.gov.

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