Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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 Amendment History 3 changes
notable Trial sites expanded: 14 -> 18 locations 2026-06-27
notable Enrollment increased: 205 -> 361 participants 2026-05-20
minor Trial arms changed: 3 -> 5 2026-05-20
Trial Details
NCT Number NCT07029399
Lead Sponsor NiKang Therapeutics, Inc.
Conditions HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
Enrollment 361 participants
Start Date 2025-03-25
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-26