drugset
drugset / Trial / NCT02175433

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

NCT02175433 ↗

Phase 1 Completed 71 enrolled Astellas Pharma Global Development, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.

Timeline

Start
2014-10-14
Primary completion
2019-10-29
Completion
2019-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject AGS67E Unknown 0.05 mg/kg Intravenous
Subject AGS67E Unknown 0.1 mg/kg Intravenous
Subject AGS67E Unknown 0.3 mg/kg Intravenous
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 1.5 mg/kg Intravenous
Subject AGS67E Unknown 1.8 mg/kg Intravenous

Indications

lymphoid hemopathy