drugset / Trial / NCT01417936

Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

NCT01417936

Phase 2 Completed 26 enrolled Symphogen A/S
NaSingle-groupOpen-labelTreatment

Summary

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN. Symphogen was the sponsor for planning/conducting and reporting results for this trial.

Timeline

Start
2011-07
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sym004 Monoclonal antibody 12 mg/kg Intravenous