drugset / Trial / NCT01148849
Safety Study of MGAH22 in HER2-positive Carcinomas
Phase 1
Completed
66 enrolled
MacroGenics
Green Cross Corporation · collabNational Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it has an effect on tumors.
Timeline
- Start
- 2010-07
- Primary completion
- 2022-06-14
- Completion
- 2022-06-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Margetuximab | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Margetuximab | Monoclonal antibody | 18 mg/kg | Intravenous |