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A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
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.
Details
| Lead sponsor | Beijing Mabworks Biotech Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 58 |
| Start date | 2021-01-04 |
| Completion | 2024-11 |
Conditions
- Advanced Malignancies
Interventions
- Recombinant Humanized Monoclonal Antibody MIL95
Primary outcomes
- Percentage of Participants with Adverse Events — up to 1year after enrollment
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Countries
China