drugset / Trial / NCT04170595
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.
Timeline
- Start
- 2014-03-28
- Primary completion
- 2021-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/kg | Oral |
| Subject | GB221 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | GB221 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | GB221 | Monoclonal antibody | 8 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |