drugset / Trial / NCT04398108
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab). The primary endpoint of this study is PK parameters of margetuximab.
Timeline
- Start
- 2020-08-25
- Primary completion
- 2021-04-27
- Completion
- 2021-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Margetuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Vinorelbine | Small molecule | — | Intravenous |