Acute Myeloid LeukemiaPhase 1/2NCT06969430
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
A Phase 1/2 study testing Debio 1562M in people with Acute Myeloid Leukemia, run by Debiopharm International SA at 7 sites in United States.
Trial summary
The primary purpose of Phase 1 is to characterize the safety and tolerability to identify the recommended dose (RD) of Debio 1562M for further development. The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Debio 1562M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 May 2025to Nov 2031
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate renal and hepatic function defined as:
- 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.
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN).
- Serum total bilirubin level ≤1.5× ULN (for participants with Gilbert's syndrome or chronic blood transfusions, total bilirubin ≤3.0× ULN).
Who cannot join
- 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:
- Hematologic malignancies other than those being investigated for which individuals are not on active antineoplastic therapy
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- 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.
- Note: Other Inclusion/Exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
The Ohio Sate University
Columbus, Ohio, 43210
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612-9416
About this study
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)
The primary purpose of Phase 1 is to characterize the safety and tolerability to identify the recommended dose (RD) of Debio 1562M for further development.
The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Debio 1562M
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio 1562MDrug
Administered as intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Dose Escalation): Debio 1562M | Experimental | Participants will receive Debio 1562M intravenously in escalating doses, once in every 3 weeks (Q3W) and once in every week (QW), 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. Receives: Drug: Debio 1562M |
| Phase 1 (Dose Optimization): Debio 1562M | Experimental | 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. Receives: Drug: Debio 1562M |
| Phase 2: Debio 1562M | Experimental | Participants will receive RD of Debio 1562M based on the results from Phase 1-Dose optimization. Receives: Drug: Debio 1562M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Measured: Up to Day 28
Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Measured: Up to Day 219
Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562M
Measured: Up to Day 198
Phase 2: Percentage of Participants With Complete Remission (CR) + CR with partial hematological recovery (CRh)
Measured: Up to Day 198
Secondary outcomes (12)
Phases 1 and 2: Overall Response (OR)
Measured: Up to Day 198
Phases 1 and 2: Percentage of Participants with CR
Measured: Up to Day 198
Phase 1: Percentage of Participants With CR+ CRh
Measured: Up to Day 198
Phases 1 and 2: Percentage of Participants With Composite Complete Remission (cCR)
Measured: Up to Day 198
Phases 1 and 2: Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplant (ASCT)
Measured: Up to Day 198
Phases 1 and 2: Change From Baseline in Blood Blast Count
Measured: Baseline upto Day 198
Phases 1 and 2: Duration of Remission (DOR)
Measured: Up to Day 198
Phases 1 and 2: Relapse Free Survival (RFS)
Measured: Up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Event Free Survival (EFS)
Measured: Up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Overall Survival (OS)
Measured: Up to Day 198
Phases 1 and 2: Plasma Concentration of Debio 1562M and its Metabolites
Measured: Pre-dose and at multiple time points up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Measured: Up to Day 219
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 May 2025
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969430
- Sponsor's protocol ID
- Debio 1562M-101
- Other IDs
- 2024-519610-32, U1111-1315-5913
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No