TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study.

ABSTRACT:

Background

Immune checkpoint inhibitor therapy has demonstrated impressive clinical benefits in multiple tumor types. TQB2450, a novel monoclonal antibody targeting programmed cell death ligand 1, has shown safety and efficacy in preclinical studies.

Objectives

This first-in-human study aimed to evaluate the safety/tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of TQB2450 in patients with advanced malignant tumors.

Design and methods

In this phase I study, eligible patients with advanced malignant tumors received intravenous TQB2450 once every 3 weeks. This study consisted of a 3 + 3 dose-escalation phase (1-30 mg/kg) and a specific dose-expansion phase (1200 mg). The primary endpoints were maximum tolerated dose (MTD), dose-li

SUBMITTER: Xue J 

PROVIDER: S-EPMC10771754 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature