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AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
RecruitingPhase 1/2
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- AB8939 (drug)
- Venetoclax (drug)
Sponsor: AB Science · Participants: 78 · Started: Jun 1, 2022
Contact the study team
- Clinical Study Coordinator · Phone: +33(0)147200014
Official record on ClinicalTrials.gov — NCT05211570
Locations in the U.S.
| Texas | MD Anderson Cancer Center, Houston (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.