Clinical Pharmacology Profile of the Claudin 18.2 Antibody Zolbetuximab.

ABSTRACT: Zolbetuximab is a first-in-class chimeric (mouse/human) monoclonal antibody targeted to the tight junction protein claudin 18.2 (CLDN18.2), an emerging biomarker in gastric/gastroesophageal junction (G/GEJ) cancer. This review summarizes the clinical pharmacology of zolbetuximab on the basis of available clinical trial data. Population pharmacokinetics (PK) were evaluated using data from eight clinical studies (n = 714). Zolbetuximab PK following intravenous administration was described by a two-compartment model with linear and time-dependent clearance components. On the basis of simulations using the 800/600 mg/m² every 3 weeks (Q3W) dosing regimen from phase 3 trials, gastrectomy (versus no gastrectomy) was predicted to increase zolbetuximab C_trough by ≥ 50%, but w

SUBMITTER: Yang J 

PROVIDER: S-EPMC12479639 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature