RecruitingPhase 1 / Phase 2

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Debio 1562M for acute myeloid leukemia (AML), a blood cancer that has come back or has not responded to treatment. The first part checks safety and finds a dose; the second part checks how well it fights leukemia. The early dose-testing part also includes people with higher-risk myelodysplastic syndrome (MDS), a disease of the bone marrow.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have AML that came back or did not respond to treatment, with no standard treatment known to help. Acute promyelocytic leukemia, a type of AML, is not included.
  • For the early dose-testing part only, people with high- or very high-risk MDS that came back or did not respond may also join if no standard treatment is known to help.
  • Be able to care for yourself and be out of bed for at least half of your waking hours.
  • Side effects from past treatment must be mild or gone, except for hair loss.
  • Past bone marrow transplants using your own cells or a donor's cells are allowed.
  • A donor transplant must have been more than 120 days before treatment. You must have no active graft-versus-host disease (donor cells attacking your body) and have stopped immune-suppressing drugs for at least 2 weeks.
  • Steroids up to the equivalent of 20 mg of prednisone are allowed, but not to suppress the immune system after a transplant or treat graft-versus-host disease.
  • Kidney filtering must be at least 60 mL/min. Liver tests AST and ALT must be no more than 3 times the normal limit. Bilirubin must be no more than 1.5 times the normal limit, or 3 times with Gilbert's syndrome or ongoing blood transfusions.

Who can't join

  • Past treatment with a drug targeting CD37, or an allergy to Debio 1562M or any of its ingredients.
  • An active infection, including hepatitis B or C, HIV, or cytomegalovirus, that the study doctor believes makes joining unsafe.
  • Serious heart problems within the past 6 months, including severe heart failure, uncontrolled chest pain, a heart attack, or certain abnormal heart rhythms; or serious active heart or lung disease.
  • Other cancers, with exceptions: other blood cancers not being actively treated, or other cancers in remission with treatment finished at least 6 months ago and side effects mild or gone.
  • Active leukemia in the brain or spinal cord. If you had this before, you need at least 2 clear spinal fluid tests and a clear brain MRI or CT scan.
  • Moderate or worse nerve damage outside the brain and spinal cord, which can cause numbness, tingling, or pain.
  • Recent leukemia treatment: within 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time for half a drug to leave the body. Hydroxyurea is allowed to control high white blood cell counts.
  • Major surgery within 4 weeks before treatment, or not yet recovered from surgery; pregnancy or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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: 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: * 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: 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. Note: Other Inclusion/Exclusion criteria may apply.

Study sites (7)

CA

FL

IL

MI

NY

OH

TX