Genmab A/S has initiated a Phase I/II study of zalutumumab (HuMax-EGFr™) in combination with irinotecan chemotherapy to treat colorectal cancer (CRC). The study will include a maximum of 97 patients who have failed standard chemotherapy and progressed during or within three months of stopping cetuximab-based therapy.
"We are glad to expand the zalutumumab program with this new indication," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial this open label study consists of two parts. In both parts of the study, patients will receive weekly doses until disease progression.
Part 1 will include 3 to 15 patients who will receive weekly doses of first 8mg/kg of zalutumumab in combination with bi-weekly irinotecan and if safe patients will subsequently receive 16 mg/kg zalutumumab in combination with irinotecan.
Part 2 will be an open label randomized parallel group enrolling 14 to 82 patients pending the number of treatment arms and early termination from part 1.
Patients in part 2 will receive weekly doses of zalutumumab with or without bi-weekly irinotecan administration until disease progression. In total a maximum of 97 patients will be enrolled into the study.
Safety data from Part 1 of the trial will be evaluated by an independent data monitoring committee who will determine if it is safe to begin Part 2. The objective of the study is to evaluate the safety and efficacy of zalutumumab in combination with irinotecan. The primary endpoint of the study is adverse events.