Statistical Analysis
The safety set (SS) consisted of all patients who received at least one dose of CB-103 and who had at least one postbaseline safety assessment. The SS was the primary population for all safety and efficacy analyses, except for determination of dose-DLT relationship. The dose-determining set was used to determinate the MTD and included all patients in the SS who had experienced a DLT at any time during cycle 1 and/or met the minimum requirements in cycle 1 (CB-103 dosed for ≥21 days, observed for ≥28-days after day 1, and completed cycle 1 safety evaluations).The objective of the BLRM design (