Actively Recruiting
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
Led by Debiopharm International SA · Updated on 2026-03-30
134
Participants Needed
7
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with relapsed or refractory acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, based on WHO Classification 2022
- For Phase 1 dose escalation: relapsed/refractory higher-risk myelodysplastic syndrome (HR-MDS) confirmed by IPSS-R
- No standard therapy of proven benefit available
- Eastern Cooperative Oncology Group performance status of 2 or less
- Previous treatment-related toxicities resolved to Grade 1 or less (excluding alopecia)
- Prior autologous or allogeneic bone marrow transplant allowed if transplant was more than 120 days before treatment and no active graft versus host disease Grade 1 or higher
- Off all immunosuppression for at least 2 weeks prior to treatment if prior allogeneic transplant
- Steroid use allowed up to 20 mg prednisone equivalent if not for post-transplant immunosuppression or graft versus host disease therapy
- Adequate kidney function: estimated glomerular filtration rate (eGFR) 60 mL/min or higher
- Adequate liver function: AST and ALT 3 times or less upper limit of normal (ULN), total bilirubin 1.5 times or less ULN (or 3.0 times ULN for Gilbert's syndrome or chronic blood transfusions)
You will not qualify if you...
- Prior exposure to cluster of differentiation (CD) 37 targeting agents
- Clinically active infections including active hepatitis B or C, HIV, cytomegalovirus or other infections deemed inappropriate for enrollment
- Clinically significant cardiac dysfunction within 6 months before enrollment including NYHA Class III or IV heart failure, uncontrolled angina, myocardial infarction, severe uncontrolled arrhythmias, QTcF >470 ms
- Clinically significant and active cardiopulmonary disease
- Other malignancies except hematologic malignancies not on active therapy and nonhematologic malignancies in remission with treatment completed at least 6 months prior and toxicities resolved to Grade 1 or less
- Evidence of active central nervous system (CNS) leukemia involvement
- Peripheral neuropathy Grade 2 or higher
- Hypersensitivity to Debio 1562M or its components
- Treatment with any antileukemic therapy within 14 days or 5 half-lives prior to trial treatment, except hydroxyurea for leukocytosis control
- Major surgery within 4 weeks prior to treatment or not recovered from surgery side effects
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 7 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States, 33612-9416
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
6
The Ohio Sate University
Columbus, Ohio, United States, 43210
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Debiopharm International S.A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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