Clinical Pharmacology Perspective on Direct-To-Subcutaneous Dosing of T Cell Engagers in Oncology First-In-Human Studies

While the subcutaneous (SC) route of administration (RoA) is more patient-centric and cost-effective than the intravenous (IV) RoA, the Switch-to-SC paradigm has been employed in oncology antibody drug development. T cell engagers (TCEs) are typically highly potent and efficacious at low doses, supporting their suitability for the Direct-to-SC in FIH paradigm. This perspective discusses anticipated clinical pharmacology challenges associated with the Direct-to-SC in FIH paradigm and provides potential solutions to address the challenges.