NCT06969430 · Debiopharm International SA
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
What this study is about
The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (gradually increasing doses) treatment group$1 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.
View original scientific description
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.
Interventions
DRUG
Debio 1562M
Administered as intravenous (IV) infusion
Primary outcome measures
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Day 219
Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562M
Time frame: Up to Day 198
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Duarte, California
- Tampa, Florida
- Chicago, Illinois
- Grand Rapids, Michigan
- Buffalo, New York
- Columbus, Ohio
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations