Clinical evaluation
Tumors, Tumor
ADVERSE EVENTS, ADVERSE EVENT, TUMOR, TUMORS
Safety and tolerability were assessed by monitoring treatment-emergent adverse events (AEs), clinical laboratory test results, vital signs, electrocardiogram measurements, left ventricular ejection fraction results, ECOG performance status, and physical examination results. Adverse events were graded by their severity (CTCAE v4.03) and categorized according to their seriousness and relationship to the study treatment.The presence of antidrug antibodies (ADAs) was evaluated in blood samples collected on Day 1 of Cycle 1 prior to the first zolbetuximab administration and during the end-of-treatment assessment. For patients who continued zolbetuximab treatment after the immunomodulation phase, blood samples for ADA evaluation were also collected at Week 13 prior to zolbetuximab administration.Tumor response was assessed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging and was evaluated using Response Evaluation Criteria in Solid Tumors v1.1 criteria. Clinical response, including objective response rate (ORR) and duration of response, was assessed.