Statistical analysis
All enrolled patients who received at least one dose of study drug were included in the efficacy and safety analysis. Patients who received at least one dose of study drug and were evaluable for DLT (experienced a DLT or completed the whole 34-day assessment period without experiencing a DLT) were included in DLT analysis. Treated patients who had post-dose PK data were included in PK analysis. All efficacy analysis was exploratory in nature. Time-to-event endpoints were estimated using the Kaplan–Meier method, with the 95% CIs calculated using the Brookmeyer and Crowley method. PK parameters were calculated using the WinNonlin noncompartmental model. Safety outcomes were summarized using descriptive statistics. All statistical analyses were done using SAS v9.4.