Statistical analyses
DLTs, ’
All patients who received at least one dose of the study treatment in the Phase 1 part of the study were included in the safety and efficacy analyses. Dose escalation and MTD assessment were primarily based on DLTs which occurred within the 28‐day observation period. Descriptive statistics were used for demographics, safety, and efficacy data. The number of patients who experienced DLTs (within and outside of the 28‐day DLT assessment period) was tabulated for each dose level. The sample size of patients required for dose escalation were determined based on the ‘3+3’ design and DLTs observed as the trial progressed.