A Study of Debio 1562M for Acute Myeloid Leukemia (AML)
This study is testing a new drug called Debio 1562M for people with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments (relapsed/refractory AML). The main goals of the first part of the study are to find a safe dose of Debio 1562M and see how well people tolerate it. Later, the study will look at how effective Debio 1562M is at fighting AML. You might be able to join if you are 18 or older and have relapsed/refractory AML or a high-risk form of myelodysplastic syndrome (MDS). The study aims to enroll 134 participants.
- Study design
- This is an interventional study, meaning participants will receive the study drug. It is not specified if it's randomized or blinded, but it will involve up to 134 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for up to 219 days, and the recommended dose will be determined within 198 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06969430
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
Recruiting
PHASE1Ages 18+InterventionalTreatmentDebiopharm International SA
~154 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Debio 1562M
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Measured over Up to Day 28
+3 more outcomes measured
Conditions
Where it's being run
7 sites across 7 statesCalifornia1
Florida1
Illinois1
Michigan1
New York1
Ohio1
Texas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For Phase 1-Dose escalation: Relapsed/refractory (R/R) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO) Classification 2022 and relapsed/refractory higher-risk myelodysplastic syndrome (R/R HR -MDS) (includes high- and very high-risk MDS) as confirmed by the Revised International Prognostic Scoring System (IPSS-R) for whom no standard therapy of proven benefit is available.
For Phase1-Dose optimization and Phase 2: R/R AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification 2022 for whom no standard therapy of proven benefit is available.
Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2.
Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding alopecia).
Individuals with prior autologous or allogeneic bone marrow (BM) transplant are eligible.
Prior allogeneic transplant must meet the following conditions: the transplant must have been performed more than 120 days before the first administration of Debio 1562M, the participant must not have ≥Grade 1 active graft versus host disease (GvHD) at the time of trial treatment start and must be off all immunosuppression for at least 2 weeks prior to starting treatment with Debio 1562M. Steroid use \[equivalent to ≤20 milligrams (mg) prednisone\] before and during the trial is allowed as long as this is not being used as post-transplant immunosuppression or graft versus host disease (GVHD) directed therapy.
Adequate renal and hepatic function defined as:
Exclusion
Any prior exposure to cluster of differentiation (CD) 37 targeting agents.
Clinically active infection including known active hepatitis B or C, human immunodeficiency virus infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the Investigator, would make a participant inappropriate for enrollment into this trial (retesting not required).
Clinically significant cardiac dysfunction within 6 months before enrollment including New York Heart Association Class III or IV heart failure, uncontrolled angina, myocardial infraction, severe uncontrolled ventricular arrhythmias, QT interval corrected for HR according to Fridericia's formula (QTcF) \>470 ms.
Clinically significant and active cardiopulmonary disease.
Other malignancies, except of:
Evidence for active central nervous system (CNS) leukemia involvement. If the participant has a prior history of CNS AML, the participant must have at least 2 negative cerebrospinal fluid (CSF) analyses and either a magnetic resonance imaging (MRI) or computed tomography (CT) (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease.
Evidence of peripheral neuropathy Grade ≥2.
History of hypersensitivity to Debio 1562M (including its components), or any of its excipients.
Treatment with any antileukemic therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agent within 14 days or within 5 half-lives of the investigational treatment prior to first dose of trial treatment, whichever is shorter. Hydroxyurea may be given prior to and after trial treatment start for control of leukocytosis.
Major surgery within 4 weeks prior to the start of treatment, or participant who have not recovered from side effects of the surgery.
Pregnancy or breastfeeding.
What this trial measures
- Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)Up to Day 28
- Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)Up to Day 219
- Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562MUp to Day 198
- Phase 2: Percentage of Participants With Complete Remission (CR) + CR with partial hematological recovery (CRh)Up to Day 198