Statistical analysis
The sample size for the dose-escalation study was estimated to be 24 based on the 3 + 3 method. Safety was analyzed in patients who received at least one dose of FCN-159 and had at least one safety assessment. DLT was assessed in the DLT analysis set, defined as patients who were enrolled in the dose-escalation study and met the DLT evaluation criteria. FCN-159 plasma concentration was analyzed in patients who received at least one dose of FCN-159, had at least one PK blood sample collection as scheduled, and had plasma concentration data for FCN-159. PK parameter analysis set comprised patients who received FCN-159 per protocol and had at least one PK parameter during the trial. Data were summarized using descriptive statistics.