Clearance as an Early Indicator of Efficacy for Therapeutic Monoclonal Antibodies: Circumventing Dose Selection Challenges in Oncology.

Clearance of mAbs can be a tumor/drug target-agnostic biomarker for potential anti-tumor activity as clearance decreases with increasing ORR. Our findings shed important insights into target clearance values that may lead to desired efficacy for different cancers and drug targets, which can be used to guide dose selection for the future development of mAbs during FIH oncology studies.