A Clinical Study of MIL95 in Advanced Malignancies.
Status:
Not yet recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This study is composed of two stages: Part A initial dose escalation and Part B maintenance
dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg
QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14
days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW).
DLT observation period is 28 days. The subject number for each cohort in Part B will be
increased to 6 if the subject number enrolled in each cohort is less than 6.