Phase I study of KN035, a novel fusion Anti-PD-L1 antibody administered subcutaneously in patients with advanced solid tumors in the USA

Abstract

Background: KN035 is a novel fusion protein of anti-PD-L1 single domain antibody and Fc, formulated for subcutaneous (SC) injection. A phase 1 dose escalation study was performed in the USA to evaluate and characterize the safety and tolerability, MTD, PK, PD and preliminary antitumor activity of single agent KN035 in patients (pts) with locally advanced or metastatic solid tumors. Method(s): Amodified 3+3 dose-escalation design was adopted with the DLT evaluation period of 28 days after the first dose of KN035, with 8 dose levels planned at 0.01, 0.03, 0.1, 0.3, 1.0, 2.5, 5 and 10 mg/kg SC weekly. Single patient cohorts were planned at the dose levels of 0.01, 0.03 and 0.1 mg/kg/dose; unless a