DB-1419

DB-1419 is a first-in-class bispecific antibody-drug conjugate (ADC) developed by DualityBio for the treatment of advanced or metastatic solid tumors. It consists of a humanized bispecific antibody targeting both B7-H3 and PD-L1, covalently linked via a cleavable linker to a novel topoisomerase I inhibitor payload (P1003). The drug is designed to combine direct cytotoxic effects on tumor cells with immune modulation. Mechanistically, it delivers its cytotoxic payload specifically to tumor cells expressing B7-H3 and/or PD-L1, leading to DNA damage and apoptosis through topoisomerase I inhibition. Additionally, by blocking the PD-1/PD-L1 interaction, it may enhance anti-tumor immune responses. Preclinical studies have shown potent antitumor activity across multiple cancer models with favorable pharmacokinetics and safety profiles. DB-1419 is currently being evaluated in global phase 1/2a clinical trials for patients with advanced/metastatic solid tumors[1][2][5][8].