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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Debiopharm International S.A contact

+41 213210111

clinicaltrials@debiopharm.com

7 sites in 1 country

United States7 sites, 7 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06969430
Study groupRoleWhat they receive
Phase 1 (Dose Escalation): Debio 1562MExperimentalParticipants 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 1562MExperimentalParticipants 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 1562MExperimentalParticipants 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.

  1. Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Measured: Up to Day 28

  2. Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

    Measured: Up to Day 219

  3. Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562M

    Measured: Up to Day 198

  4. Phase 2: Percentage of Participants With Complete Remission (CR) + CR with partial hematological recovery (CRh)

    Measured: Up to Day 198

Secondary outcomes (12)

  1. Phases 1 and 2: Overall Response (OR)

    Measured: Up to Day 198

  2. Phases 1 and 2: Percentage of Participants with CR

    Measured: Up to Day 198

  3. Phase 1: Percentage of Participants With CR+ CRh

    Measured: Up to Day 198

  4. Phases 1 and 2: Percentage of Participants With Composite Complete Remission (cCR)

    Measured: Up to Day 198

  5. Phases 1 and 2: Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplant (ASCT)

    Measured: Up to Day 198

  6. Phases 1 and 2: Change From Baseline in Blood Blast Count

    Measured: Baseline upto Day 198

  7. Phases 1 and 2: Duration of Remission (DOR)

    Measured: Up to Day 198

  8. Phases 1 and 2: Relapse Free Survival (RFS)

    Measured: Up to Day 198

  9. Phase 1 (Dose Optimization) and Phase 2: Event Free Survival (EFS)

    Measured: Up to Day 198

  10. Phase 1 (Dose Optimization) and Phase 2: Overall Survival (OS)

    Measured: Up to Day 198

  11. Phases 1 and 2: Plasma Concentration of Debio 1562M and its Metabolites

    Measured: Pre-dose and at multiple time points up to Day 198

  12. 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.

  1. First posted13 May 2025
  2. Study start30 May 2025
  3. Primary completionNov 2031 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Debiopharm International S.A (+41 213210111, clinicaltrials@debiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: Up to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06969430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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