Safety and tolerability profile
DLTs, sinus bradycardia, immune-mediated hepatitis, myasthenia gravis, TRAEs
ADVERSE EVENTS, SINUS BRADYCARDIA, MYASTHENIA GRAVIS, ADVERSE EVENT, IMMUNE-MEDIATED HEPATITIS, IMMUNE-MEDIATED MYOSITIS
In this study, 13 patients were included for the DLT analysis. DLTs were observed in one (16.7%) of the six patients at the 3 mg/kg Q2W dose level (grade 3 immune-mediated myositis and myasthenia gravis), and maximum tolerated dose (MTD) was not reached.The majority of patients (33/35, 94.3%) experienced AEs, of which 29 patients (82.9%) had QL1604-related AEs (TRAEs) (Summary of safety results (safety population).TRAE, treatment-related adverse event; AST, aspartate aminotransferase; ALT, alanine aminotransferase; TSH, thyroid-stimulating hormone; WBC, white blood cell; GT, glutamyl transpeptidase; irAE, immune-related adverse event.Grade ≥3 treatment-related adverse events (safety population).TRAE, treatment-related adverse event; GT, glutamyl transpeptidase.Serious TRAEs occurred in four (11.4%) patients. TEAEs leading to discontinuation of study drug occurred in three (8.6%) patients, including immune-mediated hepatitis (one patient), myasthenia gravis and immune-mediated myositis (one patient), and sinus bradycardia (one patient).Immune-related AEs (irAEs) occurred in 17 (48.6%) patients. The most common irAE was increased blood TSH (17.1%). Grade ≥3 irAEs occurred in four (11.4%) patients. Infusion-related reactions occurred in three (8.6%) patients, and all were grade 1 or 2.