Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety and tolerability of AGS67E in subjects with acute myeloid leukemia (AML) and determine a safe dose for future development. In addition, this study will assess the pharmacokinetics (PK), the immunogenicity, and the anti-leukemic activity of AGS67E.
The study will sequentially evaluate AGS67E given as a 30 minute intravenous (IV) infusion in
two different schedules: once every 3 weeks (Q3) and then once weekly for 3 weeks.
The dose escalation follows a 3 + 3 design.
The Data Review Team may expand any dose level or intermediate dose level that has been
deemed safe and resulted in at least one subject with a Composite Complete Remission (CRc).
An expansion cohort may enroll up to 15 subjects.
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