Population Pharmacokinetic Analysis of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors.

ABSTRACT: Datopotamab deruxtecan (Dato-DXd) is a trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) developed for the treatment of advanced or metastatic solid tumors. Dato-DXd demonstrated promising antitumor activity and a manageable safety profile in the first-in-human Phase 1 study TROPION-PanTumor01. The present work established population pharmacokinetic models for Dato-DXd and DXd in patients with advanced solid tumors, using data from three clinical studies. The final Dato-DXd model was a two-compartment model with both linear (CL_linDatoDXd) and nonlinear elimination. CL_linDatoDXd was the major elimination pathway for Dato-DXd doses ≥ 4 mg/kg, whereas nonlinear clearance was necessary to capture the concentration-dependent clearance at low

SUBMITTER: Hong Y 

PROVIDER: S-EPMC12706414 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature