drugset / Trial / NCT00775502
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.
Timeline
- Start
- 2008-10
- Primary completion
- 2011-05
- Completion
- 2011-10
Outcome
Outcome not reported
Stopped: “lack of efficacy in Multiple myeloma”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIW-8962 | Monoclonal antibody | 0.03 mg/kg | Intravenous |
| Subject | BIW-8962 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | BIW-8962 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | BIW-8962 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | BIW-8962 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | BIW-8962 | Monoclonal antibody | 10 mg/kg | Intravenous |