Aveo Oncology, a cancer therapeutics company, has commenced the Phase 1 study of its drug candidate AV-203, along with biomarkers in patients with advanced solid tumours.
Developed through the company's Human Response Platform, AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3 for treating cancer.
The Human Response Platform evaluates drugs that can block the function of cancer-causing target genes and identifies biomarkers that are indicators of drug response or resistance in patients.
The Phase 1 trial is a multicentre, dose-escalation study that will assess the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumours.
The study's secondary endpoints include characterising the pharmacokinetic (PK) profile of AV-203, anti-drug antibody levels and the preliminary anti-tumour activity.
University of Texas, US, Anderson Cancer Center medicine thoracic / head and neck medical oncology associate professor, George Blumenschein, said research has indicated that ERBB3 acts as a central node of oncogenic signalling, not only in tumour formation and proliferation across a broad range of cancer types, but also in the development of resistance to currently used EGFR and HER2 inhibitors.
"AV-203 has demonstrated potent inhibition of activated ERBB3 in a variety of human tumour models with different genetic backgrounds. I look forward to evaluating the utility of AV-203 as a potential new therapeutic option for patients living with cancer," Blumenschein added.
AV-203 has showed preclinical activity in a range of solid tumour models such as breast, head and neck, lung, ovarian and pancreatic cancers.
In March 2009, Aveo entered into an exclusive option and license agreement with Biogen Idec International, under which Aveo is responsible for developing ERBB3 antibodies through completion of the proof-of-concept clinical trial that would allow advancement to a Phase 3 study.