Statistical analysis
This trial was exploratory and aimed to enroll a fixed sample of 30 patients without formal calculation of sample size. The statistical evaluation set for determining the MTD consisted of all patients who received at least one dose of the study medication and were not replaced. Efficacy and safety endpoints were determined using descriptive exploratory analyses performed on the treated analysis set, which consisted of all patients who received at least one dose of study medication. OS and PFS were assessed based on Kaplan–Meier estimates, point estimates and confidence intervals (CIs). All analyses were performed using the software SAS