Early safety and efficacy from a phase I open-label clinical study of LVGN7409 (CD40 agonist antibody) in patients with advanced or metastatic malignancies.

摘要: e14501Background: LVGN7409 is a recombinant monoclonal antibody against CD40. The modified Fc fragment binds FcγRIIB selectively. LVGN7409 activates CD40 in Fc-FcγRIIB cross-link dependent manner and thus optimally in CD40 and FcγRIIB enriched tumor microenvironment. LVGN7409 demonstrated more robust antitumor efficacy and superior safety profile than published CD40 agonist antibodies in preclinical models. An open-label, first in human phase 1 study of LVGN7409 as a single agent, combined with LVGN3616 (anti-PD-1 antibody), and combined with LVGN3616 and LVGN6051 (CD137 agonist antibody) is ongoing. Methods: LVGN7409 was given intravenously every 3 weeks. For single agent dose-finding, LVGN7409 accelerated doses from 0.01 to 0.1mg/kg, and then conventional “3 + 3” design from 0.3 mg/kg. The objectives evaluate LVGN7409 safety, RP2D in a single agent and …