Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients - PubMed
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- #First-in-Human Dose Selection
- #T Cell Engager
- #Quantitative Systems Pharmacology
- ISB 2001 is a trispecific T cell engager targeting CD38 and BCMA on tumor cells and CD3 on T cells for treating RRMM.
- Lack of cross-reactivity in cynomolgus monkeys prevented traditional preclinical data, making FIH dose prediction challenging.
- A QSP model was used to inform FIH dose selection and predict the efficacy dose range, supporting an efficient dose escalation design in the TRIgnite-1 trial.
- This approach aligns with FDA efforts to reduce animal testing by using computational models for dose selection.
- The QSP model's predictions are being validated against preliminary safety, PK, and efficacy data from the ongoing clinical trial.