drugset
drugset / Trial / NCT02610062

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

NCT02610062 ↗

Phase 1 Terminated 23 enrolled Astellas Pharma Global Development, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-03-29
Primary completion
2017-09-22
Completion
2017-11-21

Outcome

Outcome not reported

Stopped (Business): “Business decision by sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Subject AGS67E Unknown 0.6 mg/kg Intravenous
Subject AGS67E Unknown 0.9 mg/kg Intravenous
Subject AGS67E Unknown 1.2 mg/kg Intravenous
Subject AGS67E Unknown 1.8 mg/kg Intravenous
Subject AGS67E Unknown 2.4 mg/kg Intravenous

Indications

acute myeloid leukemia