The study is being conducted at Zhongshan Hospital with Prof. Jia Fan as the principal investigator. Dr. Fan is a world-renowned liver cancer surgeon, member of the Chinese Academy of Sciences, and president of Zhongshan Hospital.

Liver cancers are highly prevalent in China, with 410,000 newly diagnosed patients (appx. 50% of all new cases worldwide) and responsible for 390,000 deaths annually. Among liver cancers, 90% are HCC. The unmet medical need for impactful novel treatments are significant for HCC treatments in China in which the 5-year survival rate for subjects with advanced disease is about 7%.

Based on previous research, TIM-3 is highly expressed by HCC, lung, and other cancers that are resistant to monoclonal antibodies targeting immune checkpoints, particularly PD-1 and PD-L1. Simultaneous inhibition of PD-1/PD-L1 and TIM-3 prevents T cell exhaustion and promotes tumor killing. Synergy has been observed with the combination of BC3402 and anti-PD-1/CTLA-4 treatment in pre-clinical and translational studies. In addition, encouraging clinical outcomes have been reported in clinical trials with other anti-TIM-3 antibodies in combination with anti-PD1/L-1 antibodies.

BioCity and AstraZeneca will work closely with the investigators to advance this clinical study. It is hoped that this trial will help demonstrate the potential clinical benefit of BC3402 in combination with durvalumab for the management of advanced HCC.