drugset / Trial / NCT04034823

KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

NCT04034823

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

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 5 mg/kg Subcutaneous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous