Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Phase 1/2 Completed 69 enrolled Prothena Biosciences Ltd.

SequentialOpen-labelTreatment

Summary

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

Timeline

Start: 2013-04
Primary completion: 2016-08-09
Completion: 2016-08-09

Publications

Gertz MA, Landau H, Comenzo RL, Seldin D, Weiss B, Zonder J, Merlini G, Schonland S, Walling J, Kinney GG, Koller M, Schenk DB, Guthrie SD, Liedtke M. First-in-Human Phase I/II Study of NEOD001 in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction. J Clin Oncol. 2016 Apr 1;34(10):1097-103. doi: 10.1200/JCO.2015.63.6530. Epub 2016 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Birtamimab	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	4 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	8 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	16 mg/kg	Intravenous
Subject	Birtamimab	Monoclonal antibody	24 mg/kg	Intravenous

Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Summary

Timeline

Publications

Drugs

Indications