Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors

Phase 1/2 Terminated 14 enrolled Krankenhaus Nordwest

NaSingle-groupOpen-labelTreatment

Summary

Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well as efficacy.

Timeline

Start: 2012-03
Primary completion: 2016-05
Completion: 2016-05

Publications

Haense N, Atmaca A, Pauligk C, Steinmetz K, Marme F, Haag GM, Rieger M, Ottmann OG, Ruf P, Lindhofer H, Al-Batran SE. A phase I trial of the trifunctional anti Her2 x anti CD3 antibody ertumaxomab in patients with advanced solid tumors. BMC Cancer. 2016 Jul 7;16:420. doi: 10.1186/s12885-016-2449-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ertumaxomab	Monoclonal antibody	10 ug	Intravenous
Subject	ertumaxomab	Monoclonal antibody	500 ug	Intravenous

Indications

No indication recorded.