Primary objective
death, Tumour, congenital anomaly, birth defect, disability/incapacity
ADVERSE EVENT, EVENT, TUMOUR
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, with assessments including clinical examinations, the assessment of AEs (especially DLT), and laboratory parameters. AEs were captured from the time of consent until 4 ± 1 weeks from the end of the last infusion of AFM11. The investigator assessed whether the AE was not/unlikely related, possibly related, probably related or definitely related to AFM11. Serious AEs (SAEs) were defined as an untoward medical occurrence that resulted in death or persistent or significant disability/incapacity, was life-threatening, required hospitalisation or was a congenital anomaly or birth defect, or an important medical event as decided by medical and scientific judgement.Tumour imaging by fluorodeoxyglucose-positron emission tomography and CT was conducted at screening and at 2 (± 1) weeks after the end of cycle 1. Responses were determined by the investigator in accordance with Cheson criteria [Antidrug antibodies (ADAs) were measured by an enzyme-linked immunosorbent assay before the first dose and at the Tumour Assessment Visit.