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.
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).
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.
Sequential
Debio 1562M
DrugAdministered as intravenous (IV) infusion
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562M
Phase 2: Percentage of Participants With Complete Remission (CR) + CR with partial hematological recovery (CRh)
Phases 1 and 2: Overall Response (OR)
Phases 1 and 2: Percentage of Participants with CR
Phase 1: Percentage of Participants With CR+ CRh
Phases 1 and 2: Percentage of Participants With Composite Complete Remission (cCR)
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