A Clinical Study of MIL95 in Advanced Malignancies.

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.

NCT Number	NCT04651348
Lead Sponsor	Beijing Mabworks Biotech Co., Ltd.
Conditions	Advanced Malignancies
Enrollment	58 participants
Start Date	2021-01-04
Primary Completion	2022-12-08 (estimated)
Study Completion	2024-11 (estimated)
Updated on ClinicalTrials.gov	2024-11-20