The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
ECOG performance status ≤ 1
Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
Patients eligible to a standard of care
Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
Patients diagnosed with acute promyelocytic leukemia (M3)
Patients with clinically active CNS leukemia
Sequential
AB8939
DrugIntravenous injection (from an initial dose of 0.9 mg/m²)
Venetoclax
Drugthe recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.
Rate of dose limiting toxicity (DLT)
Identification of the Maximal Tolerated Dose for different dosing schedules
Objective Response Rate
The proportion of patients who have a partial or complete response to therapy
