drugset / Trial / NCT04651348
A Clinical Study of MIL95 in Advanced Malignancies.
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-01-04
- Primary completion
- 2022-12-08
- Completion
- 2024-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MIL95 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 0.8 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 30 mg/kg | Intravenous |
| Subject | MIL95 | Monoclonal antibody | 45 mg/kg | Intravenous |