drugset / Trial / NCT03953833
B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2023-01-13
- Completion
- 2023-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | B003 | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | B003 | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | B003 | Monoclonal antibody | 2.4 mg/kg | Intravenous |
| Subject | B003 | Monoclonal antibody | 3.6 mg/kg | Intravenous |
| Subject | B003 | Monoclonal antibody | 4.8 mg/kg | Intravenous |