Clinical Trial

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

Recruiting Phase 1/2
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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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-13
notable Enrollment increased: 134 -> 154 participants 2026-08-13
Trial Details
NCT Number NCT06969430
Lead Sponsor Debiopharm International SA
Conditions Acute Myeloid Leukemia
Enrollment 154 participants
Start Date 2025-05-30
Primary Completion 2031-11 (estimated)
Study Completion 2031-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-12