Statistical methods
tumor
DISEASE, TUMOR
The primary analysis was performed when all responding patients in phase 2 were followed-up for up to 12 months. The RP2D was determined by the SRC after the phase 1b study, and sequential boundaries were used to monitor the DLT rate during phase 2. The sample size calculation for phase 2 is detailed in the The safety data set included all patients who received Nstat, and the efficacy data set included all patients from phase 1 and 2 with evaluable/measurable disease and ≥1 after baseline tumor assessment.