Mechanistic prediction of first-in-human dose for bispecific CD3/EpCAM T-cell engager antibody M701, using an integrated PK/PD modeling method

M701 is a bispecific CD3/EpCAM T-cell engager antibody to treat malignant ascites. This study aimed to predict in vivo exposure-cytotoxicity relationship and human pharmacokinetics (PK) characteristics of M701, as well as to design optimal starting dose and effective dose for M701 first-in-human (FIH) study. Mechanistic in vitro PK/PD model was firstly developed based on in vitro data of M701’s cytotoxicity and binding affinities with targeting...