drugset / Trial / NCT07029399
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-03-25
- Primary completion
- 2027-07-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NKT5097 | Unknown | — | Oral |
| Background | Fulvestrant | Small molecule | — | Intramuscular |
| Background | Letrozole | Other / unclassified | — | Oral |