Danish biotech firm Genmab has initiated a phase I/II study of HuMax-EGFr in combination with chemo-radiation 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 objective of the study is to investigate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation as first line treatment of patients with advanced head and neck cancer.
“We welcome the expansion of the HuMax-EGFr program, which we hope will benefit earlier stage patients,” said Lisa Drakeman, CEO of Genmab.
The 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. The safety of the dose levels will then be evaluated before dosing is continued at the next level.
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.