Statistical analysis
Due to the exploratory nature of this phase 1 study, sample sizes of the 2 parts were not determined on the basis of statistical hypotheses. For part A reported here, a total of 20 patients were planned.Safety analyses were done in patients who received study treatment and had at least one record of safety assessment. Efficacy analyses were done in the intention-to-treat population including all patients enrolled. ORR and DCR were reported, and their 95% CI were calculated via the Clopper-Pearson method. Kaplan–Meier method was used to estimate the median PFS and OS, with 95% CIs obtained by means of Greenwood’s formula.