Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05211570

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
78 (estimated)
Sponsor
AB Science · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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 determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.

Conditions

Interventions

TypeNameDescription
DRUGAB8939Intravenous injection (from an initial dose of 0.9 mg/m²)
DRUGVenetoclaxthe recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.

Timeline

Start date
2022-06-01
Primary completion
2026-08-01
Completion
2026-12-01
First posted
2022-01-27
Last updated
2025-10-02

Locations

10 sites across 4 countries: United States, France, Greece, Spain

Regulatory

Source: ClinicalTrials.gov record NCT05211570. Inclusion in this directory is not an endorsement.