RecruitingPhase 1Phase 2NCT05211570

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


Sponsor

AB Science

Enrollment

78 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AB8939 for people with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) — a blood cancer of the bone marrow — that has returned or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with AML and are eligible for second or third-line treatment - Or you have high-risk MDS that did not respond to at least two prior treatments - You are in good enough physical condition to participate (ECOG score of 1 or less for the escalation phase, 2 or less for expansion) **You may NOT be eligible if...** - You are eligible for a standard of care treatment - You are eligible for a bone marrow transplant at this time - You have a specific subtype of AML called acute promyelocytic leukemia (APL/M3) - You have leukemia that has spread to the brain or spinal fluid - You had a stem cell transplant within the past 100 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Houston, Texas, United States

Institut Paoli Calmettes

Marseille, France

National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit

Athens, Greece

General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)

Alicante, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Quirónsalud

Madrid, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)

Seville, Spain

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NCT05211570


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