The multi-dose, single-arm, multi-centre, open-label, dose-escalation Phase I study is designed to define the toxicity profile, maximum tolerated dose, immunogenicity, pharmacokinetics, and potential anti-tumour activity of MGAH22.
The study will evaluate MGAH22 in patients with refractory HER2-positive breast cancer and patients with other carcinomas that overexpress HER2 for whom no standard therapy is available.
MGAH22 is an Fc-modified monoclonal antibody targeting the HER2 oncoprotein, which is overexpressed on the surface of various cancer cells and plays a primary role in tumorigenesis, tumor aggressiveness, and outcome in breast and other cancers.