LEADS BIOLABS-B (09887) announced that the first patient has been successfully dosed in a Phase II clinical study evaluating oplitelimab (PD-L1/4-1BB bispecific antibody LBL-024) as a first-line treatment for hepatocellular carcinoma (HCC). This milestone marks the efficient advancement of the core product's expanded indications.
The open-label, multicenter Phase II study is led by Professor Jian Zhou from Zhongshan Hospital, Fudan University, and is being conducted simultaneously across multiple hospitals nationwide. The trial aims to assess the efficacy and safety of oplitelimab in combination therapy for first-line HCC treatment.
LBL-024 is a bispecific antibody targeting both PD-L1 and 4-1BB, representing the first globally developed 4-1BB receptor-targeted therapy to reach the registration clinical stage for extrapulmonary neuroendocrine carcinoma. It also holds potential to become the first approved treatment for advanced extrapulmonary neuroendocrine carcinoma.
Leveraging the proprietary X-body® platform, LBL-024 adopts an optimized 2:2 structural design, which counteracts PD-1/L1-mediated immune suppression while enhancing 4-1BB-regulated T-cell activation, achieving synergistic tumor elimination. This mechanism suggests broader-spectrum anticancer potential compared to PD-1/L1 inhibitors alone.