drugset / Trial / NCT06969430
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
RandomizedSequentialOpen-labelTreatment
Summary
The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
Timeline
- Start
- 2025-05-30
- Primary completion
- 2031-11
- Completion
- 2031-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Debio 1562M | Unknown | — | Intravenous |