Statistical Analysis
There was no formal sample size calculation based on statistical hypothesis testing for this study; the planned enrolment was approximately 30-60 patients across the dose-escalation and dose-expansion cohorts. The actual number in the dose-escalation cohort was adjusted based on the number of dose cohorts required for the modified Fibonacci dose-escalation design and the determined MTD. Definitions for all analysis populations (safety, DLT, PK, and efficacy [intent-to-treat, ITT]) are provided in 