Study design
toxicity
This was an open-label, single-arm, dose-escalation/dose-expansion, phase I study comprising two phases: a dose-escalation phase and an expansion phase. The dose-escalation phase adopted a standard 3 + 3 design to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended phase II dose (RP2D) of HL-085. In the dose-expansion phase, patients were administered at the RP2D to further evaluate the safety and efficacy of the HL-085.This study was approved by local institutional review boards and ethics committee at each trial center and was conducted in line with good clinical practice guidelines, Declaration of Helsinki, and relevant regulations. Prior to study initiation, all patients provided written informed consent. The study protocol was registered at clinicaltrials.gov (NCT03973151).