LEADS BIOLABS-B (09887): Phase II Study of Vilisin™ for Biliary Tract Cancer Progresses to Expansion Phase

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LEADS BIOLABS-B (09887) announced that the Phase II clinical study evaluating Vilisin™ (PD-L1/4-1BB bispecific antibody Opatisumimab, LBL-024) as a first-line treatment for advanced biliary tract cancer has completed the preliminary assessment of the safety run-in period. Based on favorable safety and encouraging preliminary efficacy data, the study has successfully advanced to the expansion phase, with the first patient already enrolled. The study is led by Academician Zhou Jian from Zhongshan Hospital, Fudan University, and is being conducted concurrently across multiple hospitals in China. During the safety run-in period, a total of 20 subjects completed the preliminary evaluation. Data indicated that Vilisin™ in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy data also showed a promising trend of tumor shrinkage. Encouraged by the positive safety and efficacy results, the study has now entered the expansion phase and is accelerating its progress.

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