CetuGEX showed improved anti-tumor activities, reduced side effects and a broader patient and indication range.
The 1:1 randomized Phase IIb trial is designed to assess the efficacy and safety of CetuGEX combined with chemotherapy compared to cetuximab plus chemotherapy as a first line treatment of patients suffering from recurrent and/or metastatic SCCHN.
About 240 patients with SCCHN are expected to be enrolled at more than 40 sites in seven European countries and the US.
In a single agent Phase I trial, CetuGEX was well tolerated and demonstrated convincing therapeutic activity in treating patients with various solid cancers who were progressive at inclusion.
In addition, there were noticeably lesser side effects with CetuGEX compared to other EGFR targeting molecules.
In this trial CetuGEX showed a clinical benefit rate (CBR) of 82% (22/28) of evaluable patients with several complete and partial responses over all dose ranges (12 to 1370 mg).
Glycotope CEO, CSO and founder Steffen Goletz said the start of the Phase IIb trial is an important milestone for the company, not only in the clinical development of CetuGEX but also for its comprehensive pipeline of immune enhanced anti-cancer antibodies.
"Already as single agent in the Phase I clinical trial CetuGEX has achieved a larger series of strong, long-lasting responses and clinical benefit in patients with progressive solid cancers combined with lesser side effects, especially in respect to typical skin reactions of EGFR therapies," Goletz said.
"These results give us great confidence to enter into larger Phase IIb trials."