Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab

We present a novel approach for first-in-human (FIH) dose selection of the CD20xCD3 bispecific antibody, glofitamab, based on pharmacokinetic/pharmacodynamic (PKPD) assessment in cynomolgus monkeys to select a high, safe starting dose, with cytokine release (CR) as the PD endpoint. Glofitamab pharma...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2022-04, Vol.111 (4), p.1208-1218
Hauptverfasser:	Frances, Nicolas, Bacac, Marina, Bray-French, Katharine, Christen, François, Hinton, Heather, Husar, Elisabeth, Quackenbush, Elizabeth, Schäfer, Martin, Schick, Eginhard, Vyver, Arthur Van De, Richter, Wolfgang F.
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Antibodies, Bispecific Antibody drug(s) Antibody(s) Cytokines Humans IgG antibody(s) Interleukin-6 Interspecies (dose) scaling Lymphoma, B-Cell - drug therapy Lymphoma, B-Cell - pathology Macaca fascicularis Mice Monoclonal antibody(s) Pharmacodynamics Pharmacokinetics
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