Assessments
death, Tumor, treatment-emergent adverse, abnormality/birth defect, disability/incapacity
EVENT, TUMOR
Safety was assessed by physical examination, laboratory test abnormalities, and treatment-emergent adverse events (TEAE). TEAEs were listed by preferred term and system organ class using the Medical Dictionary for Regulatory Activities version 23.1 and categorized by grade using NCI CTCAE version 4.03 criteria. TEAEs were considered to be serious if they were life threatening, a medically important event, or a congenital abnormality/birth defect, or resulted in death, inpatient hospitalization or prolongation of hospitalization, or persistent or significant disability/incapacity.The pharmacokinetics of tusamitamab ravtansine in plasma were evaluated during cycle 1. A validated immunoassay (lower limit of quantitation = 0.500 μg/mL) that quantifies conjugated antibody carrying at least one DM4 payload was used to determine plasma drug concentrations (Tumor assessments were carried out according to RECIST version 1.1 criteria at baseline, at the end of every 4 cycles (for cohort Q2W-LD) and every 2 cycles (for cohort Q3W), and at the end of treatment.