A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
NCT ID: NCT06969430
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
134 participants
INTERVENTIONAL
2025-05-30
2031-11-30
Brief Summary
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The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 (Dose Escalation): Debio 1562M
Participants will receive Debio 1562M intravenously in escalating doses, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.
Debio 1562M
Administered as intravenous (IV) infusion
Phase 1 (Dose Optimization): Debio 1562M
Participants will be randomised 1:1 to receive 1 of the 2 Debio 1562M dose(s) and/or dosing schedule(s) selected based on the results from the Phase 1-Dose escalation for further investigation.
Participants will be randomized to receive one of the 2 selected doses from Phase 1 (dose escalation) for further investigation and selection of recommended dose (RD) for Phase 2. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.
Debio 1562M
Administered as intravenous (IV) infusion
Phase 2: Debio 1562M
Participants will receive RD of Debio 1562M based on the results from Phase 1-Dose optimization. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.
Debio 1562M
Administered as intravenous (IV) infusion
Interventions
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Debio 1562M
Administered as intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Estimated glomerular filtration rate (eGFR) ≥60 milliliter per minute (mL/min) based on the chronic kidney disease-Epidemiology Collaboration based on creatinine (CKD-EPIcr) 2021 equation.
2. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN).
3. Serum total bilirubin level ≤1.5× ULN (for participants with Gilbert's syndrome or chronic blood transfusions, total bilirubin ≤3.0× ULN).
Exclusion Criteria
* 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:
1. Hematologic malignancies other than those being investigated for which individuals are not on active antineoplastic therapy
2. Nonhematologic malignancies in remission and for which individuals must have completed all antineoplastic therapy at least 6 months before trial treatment start and all treatment-related toxicities must have resolved to ≤Grade 1.
* 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.
18 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2024-519610-32
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1315-5913
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 1562M-101
Identifier Type: -
Identifier Source: org_study_id