- Dose escalation started at dose level 1 and was carried out according to standard 3+3 design. The plan was as follows: If zero of three patients experiences DLT, dose escalation would proceed to the next higher dose level, at which three patients will be enrolled. The cohort would be expanded to six patients. Dose escalation would continue if no greater than one of six patients experience DLT, up to a maximum dose of 4 mg.