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


Study Number
4399025
Phase
I/II
Age Group
Adult
Purpose

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.

Full Title

A Phase 1/2, first-in-human, multicenter, open-label trial evaluating the safety, tolerability,
and antileukemic activity of Debio 1562M in participants with acute myeloid leukemia (AML)

ClinicalTrials.Gov ID
NCT06969430

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.