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Recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06969430

Public ClinicalTrials.gov record NCT06969430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06969430
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Debiopharm International SA
Industry
Enrollment
154 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 29, 2025
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031
Last update posted
Aug 11, 2026

2025 – 2031

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
City of Hope Comprehensive Cancer Center Duarte California 91010 Recruiting
Moffitt Cancer Center and Research Institute Hospital Tampa Florida 33612-9416 Recruiting
University of Chicago Chicago Illinois 60637 Recruiting
START Midwest Grand Rapids Michigan 49546 Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York 14203 Recruiting
The Ohio Sate University Columbus Ohio 43210 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06969430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06969430 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →