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RECRUITING
NCT06969430
PHASE1/PHASE2

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

Sponsor: Debiopharm International SA

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2025-05-30

Completion Date

2031-11

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Debio 1562M

Administered as intravenous (IV) infusion

Locations (7)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

START Midwest

Grand Rapids, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

The Ohio Sate University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States