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
Inclusion Criteria10
- DOSE ESCALATION 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.
- 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
- 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
Exclusion Criteria15
- 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
- EXPANSION COHORT STUDY
- 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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05211570
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