Clinical validation of a quantitative systems pharmacology (QSP) model of ISB 2001 used for deriving first in human (FIH) dose and efficient phase 1 dose escalation design in relapsed/refractory multiple myeloma (RRMM) patient

In partnership with Ichnos, Certara developed a QSP model to determine the most suitable therapeutic dose for their tri-specific T-cell engager. Despite the absence of monkey PK and toxicology data, this QSP-guided approach successfully predicted an optimal FIH dose, clinical PK, safety, and anti-myeloma activity, while minimizing patient exposure to sub-therapeutic doses. The QSP-based FIH estimation and efficacy dose range estimation offer an effective pathway for designing phase 1 studies for future TCEs.

Authors: Vinu Menon, Beata Holkova, Lida Pacaud, Sunitha GN, Andrew Garton, Maria Pihlgren, Tomomi Matsuura, Piet H. van der Graaf, Mario Perro, Cyril Konto