drugset / Trial / NCT01021072

A First in Man Study of MABp1 in Patients With Advanced Cancers

NCT01021072

Phase 1 Completed 52 enrolled Janssen Research & Development, LLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process. An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.

Timeline

Start
2010-03-31
Primary completion
2012-10-31
Completion
2013-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bermekimab Monoclonal antibody 0.25 mg/kg Intravenous
Subject Bermekimab Monoclonal antibody 0.75 mg/kg Intravenous
Subject Bermekimab Monoclonal antibody 1.25 mg/kg Intravenous
Subject Bermekimab Monoclonal antibody 3.75 mg/kg Intravenous