Statistical analysis
DLTs
Since the study was primarily a descriptive safety and tolerability assessment, no formal sample size estimate was performed, but we included at least three patients at each dose level to identify any DLTs and 20 patients to determine antitumor activity. Both efficacy and safety were assessed in the full analysis set (FAS), which included all patients who were assigned to treatment in the dose-escalation part (FAS 1) or dose-expansion part (FAS 2). Demographics and baseline characteristics were summarized using descriptive statistics and/or frequency as appropriate. Efficacy variables were summarized using descriptive statistics, with 95% confidence intervals (CIs) calculated for ORR. Time-to-event endpoints were assessed using frequency, median, quartiles, range, and rate within each 90-day period, as well as by Kaplan–Meier curves. Missing data were not imputed.