AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT05211570 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: AB180012020-005122-28
• Study Type: interventional
• Target: 78
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia, in Relapse; Myelodysplastic Syndrome Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of dose limiting toxicity (DLT)

  Identification of the Maximal Tolerated Dose for different dosing schedules

  Up to 56 days

Secondary Outcomes (1)

• Objective Response Rate

  Up to 56 days

Study Arms (2)

AB8939

EXPERIMENTAL

AB8939 administered as a single agent

Drug: AB8939

AB8939 plus Venetoclax

EXPERIMENTAL

AB8939 administered in combination with venetoclax

Drug: AB8939; Drug: Venetoclax

Interventions

AB8939 DRUG

Intravenous injection (from an initial dose of 0.9 mg/m²)

AB8939; AB8939 plus Venetoclax

Venetoclax DRUG

the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.

AB8939 plus Venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 are able and willing to comply with study procedures as per protocol, including bone marrow biopsies

You may not qualify if:

• Patients eligible to a standard of care
• Patients diagnosed with acute promyelocytic leukemia (M3)
• Patients with clinically active CNS leukemia
• Patients with HSCT within 100 days prior to the first administration of AB8939
• Women who are lactating/breastfeeding or who plan to breastfeed while on study
• Women with a positive pregnancy test
• EXPANSION COHORT 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.
• ECOG performance status ≤ 2
• Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
• Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
• Patients eligible to a standard of care
• Patients diagnosed with acute promyelocytic leukemia (M3)
• Patients with clinically active CNS leukemia
• Patients with HSCT within 100 days prior to the first administration of AB8939

Sponsors & Collaborators

• AB Science: lead

Study Sites (10)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Institut Paoli Calmettes

Marseille, France

NOT YET RECRUITING

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

Athens, Greece

RECRUITING

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

Alicante, Spain

RECRUITING

Hospital San Pedro de Alcantara

Cáceres, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Quirónsalud

Madrid, Spain

RECRUITING

MD Anderson Cancer Center Madrid

Madrid, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Spain

RECRUITING

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

Seville, Spain

RECRUITING

Related Publications (3)

• Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143

  BACKGROUND

• Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021

  BACKGROUND

• Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540

  BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; GATA2 Deficiency

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Norbert Vey, MD

  Institut Paoli Calmettes, Marseille, France

  PRINCIPAL INVESTIGATOR

• Nicholas Short, MD

  MD Anderson Cancer Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Study Coordinator

CONTACT

+33(0)147200014; clinical@ab-science.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, multi-centre, non-randomized, 2-part study

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 27, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

GR (1); ES (7); FR (1); US (1)