Clinical trial · Interventional
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
NCT05211570CI-TRIAL-00096157recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia Refractory | — | UNRESOLVED | — |
| Myelodysplastic Syndrome Acute Myeloid Leukemia | Myelodysplastic Syndrome/Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AB8939 | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AB8939
- description
- AB8939 administered as a single agent
- interventionNames
- Drug: AB8939
- type
- EXPERIMENTAL
- label
- AB8939 plus Venetoclax
- description
- AB8939 administered in combination with venetoclax
- interventionNames
- Drug: AB8939
- Drug: Venetoclax
Primary outcomes (1)
- measure
- Rate of dose limiting toxicity (DLT)
- timeFrame
- Up to 56 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * 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 Other protocol-defined inclusion/exclusion criteria may apply EXPANSION COHORT 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. * 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 Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * 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 Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (3)
- BACKGROUNDGoubard 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
- BACKGROUNDGoubard 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
- BACKGROUNDHumbert 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