Safety assessment
Cancer
ADVERSE EVENT, CANCER
AEs were assessed from the initiation of drug administration to D42 ± 2 days or 28 ± 2 days after the last administration. AEs were classified according to Medical Dictionary for Regulatory Activities (MedDRA) v24.0. The severities of AEs were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with grade 1 being mild, grade 2 being moderate, and grades 3–5 being severe. The analyzed PK parameters included the area under the plasma concentration–time profile (AUC