drugset / Trial / NCT06969430

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430 ↗

Phase 1/2 Recruiting 134 enrolled Debiopharm International SA
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

EvaluationDrugModalityDoseRoute
Subject Debio 1562M Unknown — Intravenous