A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
AB Science
Summary
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.
Description
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 determi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
DOSE ESCALATION STUDY Key Inclusion Criteria: * 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 *…
Interventions
- DrugAB8939
Intravenous injection (from an initial dose of 0.9 mg/m²)
- DrugVenetoclax
the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.
Locations (10)
- MD Anderson Cancer CenterHouston, Texas
- Institut Paoli CalmettesMarseille
- National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation UnitAthens
- General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)Alicante
- Hospital San Pedro de AlcantaraCáceres
- Hospital Universitario 12 de OctubreMadrid