Model-Informed Optimal Dosing of Anti-CD47 Antibody Using Target-Mediated Drug Disposition Model.

ABSTRACT: IMC-002, an anti-cluster of differentiation 47 (CD47) antibody, was developed as a fully human immunoglobulin (Ig) G4 monoclonal antibody targeting CD47. IMC-002 blocks CD47-signal regulatory protein alpha (SIRPα) interactions, increasing the phagocytosis of cancer cells by macrophages. This study established a target-mediated drug disposition (TMDD) pharmacokinetics (PK) model for IMC-002 to explain the characteristics of the neonatal Fc receptor (FcRn) of IgG based on phase I_a trial data to perform model-informed optimal dosing for a phase I_b study. The PK data were obtained from a phase I_a dose escalation study on 12 patients with advanced solid tumors. Each patient received multiple doses (5, 10, 20, or 30 mg/kg) via intravenous infusion over 3 h every

SUBMITTER: Jeong S 

PROVIDER: S-EPMC12370379 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature