drugset / Trial / NCT04034823
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2021-01-01
- Completion
- 2022-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 5 mg/kg | Subcutaneous |
| Background | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |