LEADS BIOLABS-B(09887): VelixinTM treatment for stage II cholangiocarcinoma study successfully enters the expansion phase.

LEADS BIOLABS-B(09887) announced that the Phase II clinical study evaluating the safety of the dual-specificity antibody Opaticsumab (PD-L1/4-1BB) for first-line treatment of advanced cholangiocarcinoma has completed the safety lead-in phase. Based on good safety and promising preliminary efficacy data, the study has successfully advanced to the expansion stage, with the first patient already enrolled. The study is led by Academician Jian Zhou of Zhongshan Hospital Affiliated to Fudan University and is being conducted simultaneously in multiple hospitals across the country. During the safety lead-in phase, a total of 20 subjects completed the initial evaluation. The data showed that the combination of Opaticsumab and chemotherapy was well tolerated and showed good safety overall, with no new safety signals identified. Preliminary efficacy data also showed a promising trend of tumor shrinkage. With the good safety and promising efficacy data, the study has entered the expansion phase and is being accelerated.