RecruitingPhase 1Phase 2NCT06969430

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

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)


Sponsor

Debiopharm International SA

Enrollment

134 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called Debio 1562M in people with acute myeloid leukemia (AML) — a fast-growing blood cancer — or with high-risk myelodysplastic syndrome (a condition where bone marrow doesn't make enough healthy blood cells), particularly when other treatments have stopped working. **You may be eligible if...** - You have been diagnosed with AML or high-risk MDS that has relapsed or is no longer responding to standard treatments - You are in generally good health despite your diagnosis - Your organ function (kidneys, liver, heart) meets the study's minimum requirements - You are willing to use effective contraception during and after the study **You may NOT be eligible if...** - You have a type of AML called acute promyelocytic leukemia (APL) - You have active, uncontrolled infection or severe organ failure - You have received certain prior therapies within specific timeframes - You are pregnant or breastfeeding - You have known HIV or active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDebio 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06969430


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