Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study.

ABSTRACT:

Background

Tislelizumab is an investigational, humanized, IgG4 monoclonal antibody with high affinity and binding specificity for programmed cell death-1 (PD-1) that was engineered to minimize binding to FcγR on macrophages in order to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy.

Methods

The purpose of this phase 1/2, open-label, non-comparative study was to examine the safety, tolerability, and antitumor activity of tislelizumab in adult (≥18 years) Chinese patients with histologically or cytologically confirmed advanced solid tumors with measurable disease. The phase 1 portion of the study consisted of a dose-verification study and a pharmacokinetic (PK) substudy; phase 2 was an indication-expansio

SUBMITTER: Shen L 

PROVIDER: S-EPMC7304812 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature