Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (AML) and to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose [RP2D]).
Full description
This is a first-in-human, open-label, phase 1, sequential dose escalation study. Emerfetamab will be evaluated as a short term intravenous (IV) infusion in adults with relapsed/refractory AML The study will consist of a dose escalation phase and a dose expansion phase. The study was terminated prior to the start of the expansion phase.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
Subjects ≥ 18 years of age at the time of signing consent.
AML as defined by the World Health Organisation (WHO) Classification persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (APML).
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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