Clinical Trials

CetuGEX™ is a novel immune enhanced anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) for the treatment of non small cell lung cancer (NSCLC), metastatic colorectal cancer (CRC), head and neck cancers as well as gastric and renal cancers with optimized and fully human glycosylation.
CetuGEX™ expresses several anti-tumor modes of action, a very strong antibody dependent cellular toxicity (ADCC), efficient proliferation inhibition via receptor blockage and apoptosis induction. Based on the optimization of a series of sugar determinants CetuGEX™ is 10 to 250-fold more active in anti-tumor ADCC compared to cetuximab making it highly potent for patients of all ADCC receptor allotypes and KRAS mutant patients. The molecule has an optimized bioavailability, lacks foreign immunogenic carbohydrates and has shown a largely improved side effect profile compared to other EGFR antibodies such as low grade and low incidence of skin rash in combination with a strong single agent activity. These improvements aim for an expansion of the number of suitable patients as well as indications.

The 1:1 randomized Phase IIb study is designed to evaluate 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 squamous cell carcinoma of the head and neck (SCCHN). A total of approximately 240 SCCHN patients are planned to be enrolled at more than 40 sites in seven European countries and the USA. (NCT02052960)

In a single agent Phase I trial CetuGEX™) was well tolerated and showed convincing therapeutic activity in treating patients with various solid cancers who were progressive at inclusion. Furthermore, there were noticeably lesser side effects (e.g. skin reactions) with CetuGEX™ compared to other EGFR targeting molecules.

In this trial CetuGEX™ demonstrated a clinical benefit rate (CBR) of 82% (22/28) of evaluable patients with several complete and partial responses (objective response rate ORR = 18%) over all dose ranges (12 to 1370 mg). Clinical benefit was often long lasting and occurred in patients where EGFR therapy had previously failed and in several non-typical EGFR indications. Longest benefit with >870 days is a complete response (CR) in a lung cancer patient (still ongoing), and 80% of the responses lasted over 400 days. CetuGEX™ was well tolerated with a low rate and low grade (only grade 1 or 2) of skin reactions (29% skin rash and 24% acneiform dermatitis, partially overlapping) compared to other EGFR targeting molecules.

Cetu-GEX™ is the second of Glycotope\'s antibodies in Phase IIb.