1754-1755 / 2437
• If none of the first 3 evaluable patients in a dose cohort
experience a DLT, then enrollment into the next higher dose
cohort can be initiated.
• If 1 of the first 3 evaluable patients in a dose cohort experiences
a DLT, then an additional 3 patients will be enrolled into the same
cohort.
• If 1/6 evaluable patients in the expanded 6-patient cohort
experiences a DLT, then the next higher dose cohort can be
tested and enrollment of the next 3 patients at the next higher
dose level can be initiated.
• If ≥ 2/6 evaluable patients in the expanded 6-patient cohort
experience a DLT, then the MTD has been exceeded and no
further dose-escalation will occur.
MRZ-112 trial: 3+3 design