Statistical analysis
MAY
The sample size was determined based on the primary efficacy endpoint. An interim efficacy analysis was performed when the first 18 (Cohort A1), 12 (Cohort A2), 17 (Cohort B), and 11 (Cohort C) patients in Phase 2 had been treated and the last patient in Phase 2 had been followed up for 24 weeks (data cutoff: 5 May 2020, for Cohorts B and C; 18 August 2020, for Cohort A1; 15 February 2021, for Cohort A2).CR and ORR rates were summarized using descriptive statistics. A 90% two‐sided confidence interval (CI) was computed using the Clopper–Pearson method. Efficacy evaluation was based on Simon's 2‐stage design with 85% power at a 1‐sided alpha level of 5% for each cohort. Duration of response, median PFS, and 95% CIs were calculated using the Kaplan–Meier method. Individual concentrations and pharmacokinetic parameters of Isa were summarized by descriptive statistics.