A Phase 1/2 interventional study of AB8939 and Venetoclax in Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse and Myelodysplastic Syndrome Acute Myeloid Leukemia, sponsored by AB Science. Recruiting at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by AB Science · Phase 1/2, Interventional, and Treatment
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.
This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome.
Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's planned enrollment of 78 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →AB Science is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
DOSE ESCALATION STUDY
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
EXPANSION COHORT STUDY
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
AB8939 administered as a single agent
Drug: AB8939
AB8939 administered in combination with venetoclax
Drug: AB8939 · Drug: Venetoclax
Intravenous injection (from an initial dose of 0.9 mg/m²)
the 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
Time frame: Up to 56 days
Objective Response Rate
The proportion of patients who have a partial or complete response to therapy
Time frame: Up to 56 days
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