LEADS BIOLABS-B (09887) announced that the first patient has been successfully dosed in a Phase II clinical trial evaluating oplitelimab (PD-L1/4-1BB bispecific antibody LBL-024) as a first-line treatment for biliary tract cancer. This milestone highlights the rapid progress in expanding indications for this core product.

The open-label, multicenter Phase II study is led by Professor Zhou Jian 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 advanced biliary tract cancer patients.

LBL-024 is a bispecific antibody targeting both PD-L1 and 4-1BB, making it the first globally developed 4-1BB receptor-targeted therapy for extra-pulmonary neuroendocrine carcinoma to reach the registration clinical stage. It also holds potential as the first approved treatment for advanced extra-pulmonary neuroendocrine carcinoma.

Developed using the proprietary X-bodyTM platform, LBL-024 features an optimized 2:2 structural design that alleviates PD-1/L1-mediated immune suppression while enhancing 4-1BB-regulated T-cell activation, achieving synergistic tumor elimination. This gives it broader-spectrum anticancer potential compared to PD-1/L1 inhibitors alone.

In April 2024, the company received approval from China's National Medical Products Administration (NMPA) to initiate a single-arm registration clinical trial. By October 2024, LBL-024 secured Breakthrough Therapy Designation (BTD) from the NMPA for post-line advanced extra-pulmonary neuroendocrine carcinoma. In November 2024, the U.S. Food and Drug Administration (FDA) granted LBL-024 Orphan Drug Designation (ODD) for neuroendocrine carcinoma treatment.