Genmab initiates safety study of zalutumumab

Danish drug developer Genmab AS has initiated a Phase I/II study of zalutumumab (HuMax-EGFr) in combination with radiotherapy for the treatment of advanced head and neck cancer. The study will include a maximum of 36 patients who are ineligible for platinum-based chemotherapy.

In the dose-escalation part of the study, six to 24 patients will be enrolled in cohorts of three subjects per dose level of zalutumumab, which will be determined by the aggregate safety data observed in the prior groups. When the maximum-tolerated dose of the drug is established, an additional cohort of 12 patients will be enrolled and treated at this level.

Patients in the study will receive eight weekly infusions of zalutumumab with the first cohort receiving an initial dose of 12mg/kg of zalutumumab followed by seven maintenance doses of 8mg/kg of zalutumumab in addition to radiotherapy. Participants will be evaluated at four weeks following the last dose of the compound and will be assessed for a total of two years.