AVEO Oncology Inc. said it has entered into a clinical trial collaboration and supply agreement in North America with Eli Lilly & Co. to evaluate ficlatuzumab in combination with Erbitux cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Under the terms of the agreement, Lilly will provide cetuximab clinical drug supply in the U.S. and Canada for AVEO’s potential registrational study, which will assess ficlatuzumab with cetuximab in HPV negative recurrent or metastatic head and neck squamous cell carcinoma, AVEO said. AVEO will serve as the study sponsor and will be responsible for trial execution.
Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.
AVEO began manufacturing ficlatuzumab clinical supply in the second quarter of 2022, and the potential registrational study is expected to be initiated in the first half of 2023, it said.
AVEO said it expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.
AVEO shares were up 3% to $4.95 in premarket trading.