Statistical analysis
toxicities, death
DISEASE PROGRESSION, DISEASE, BEST
All patients who received any dose of study treatment were included in safety and efficacy analyses. For safety analyses, the frequency and percentage of patients with dose-limiting toxicities and AEs were presented for each cohort. Best overall response per RECIST v1.1 with confirmation on CR and PR were represented by frequency, percentage, and 95% confidence interval (CI) with the Clopper-Pearson Confidence Interval method. PFS, DOR, and OS were analyzed using the Kaplan–Meier method. PFS was defined as the time from the date of first study treatment to the first date of documented progression or death due to any cause. For patients who were not known to have died or progressed as of the cut-off dates, PFS times were censored at the date of the last progression-free disease assessment prior to the date of any subsequent anticancer therapy. DOR was measured from the date of the first documented response to the date of first disease progression or the date of death due to any cause, using the same censoring rules as PFS. OS was defined as the time from the date of first study treatment to the date of death from any cause. For each patient who was not known to have died as of the cut-off date, OS data were censored for that analysis at the date of last contact prior to the data inclusion cutoff date. SAS 9.4 was used for analyses on the clinical data for demographics, baseline characteristics, safety, and efficacy.