GENMAB INITIATES TRIAL OF CANCER THERAPY

Genmab has initiated a Phase I/II study of HuMax-EGFr (zalutumumab) in combination with chemotherapy as first line treatment of head and neck cancer. The study will include a total of 36 patients with advanced squamous-cell carcinoma of the head and neck.

The open-label study consists of an initial dose-escalation part and a subsequent parallel group design. In the dose-escalation part of the study, three dose levels of HuMax-EGFr will be tested in combination with conventional fractionated radiotherapy and cisplatin. Patients in the first treatment group will receive one initial dose of 8 mg/kg of HuMax-EGFr followed by seven weekly maintenance doses of 4 mg/kg. The safety of this dose level will then be evaluated before dosing is continued at the next level. The planned dosing for the two other dose groups is an initial dose of 12 or 16 mg/kg followed by seven weekly maintenance doses of 8 or 12 mg/kg, respectively, but can be adjusted according to safety data from the first treatment group.

In the following parallel group design part of the study, HuMax-EGFr will be tested in combination with cisplatin and three different regimes of accelerated radiotherapy. All patients in the study will be evaluated four weeks after administration of the last dose of HuMax-EGFr and will be followed for at least three years.