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BL-M07D1 + PD-1 monoclonal antibody is a combination therapy under investigation for the treatment of unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. **BL-M07D1** is a HER2-targeted antibody-drug conjugate (ADC) composed of the humanized antibody trastuzumab, a cathepsin B cleavable linker, and Ed-04, a camptothecin-derived topoisomerase I inhibitor, which induces cytotoxicity by inhibiting DNA topoisomerase I and causing cell cycle arrest and apoptosis. **PD-1 monoclonal antibodies** are immune checkpoint inhibitors that block the interaction between PD-1 on T cells and its ligands, restoring T cell function and promoting anti-tumor immunity. The rationale behind the combination is to directly target and kill HER2-positive tumor cells via the ADC, while also unleashing host immune responses against the tumor by disrupting immune checkpoints. This combination is being tested in phase II clinical trials for gastric cancer and has shown promising preclinical and emerging clinical safety and efficacy. The therapy is in clinical trials sponsored by Sichuan Baili Pharmaceutical and Baili-Bio (Chengdu) Pharmaceutical.
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