drugset / Trial / NCT04382352

B002 in Patients With HER2-positive Breast Cancer

NCT04382352 ↗

Phase 1 Completed 23 enrolled Shanghai Pharmaceuticals Holding Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

To assess the safety and tolerability characteristics of B002 in patients with HER2-positive recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the maximum tolerated dose (MTD) was explored.

Timeline

Start
2019-05-28
Primary completion
2022-04-26
Completion
2022-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject B002 Monoclonal antibody 2 mg/kg Intravenous
Subject B002 Monoclonal antibody 6 mg/kg Intravenous
Subject B002 Monoclonal antibody 12 mg/kg Intravenous
Subject B002 Monoclonal antibody 16 mg/kg Intravenous
Subject B002 Monoclonal antibody 20 mg/kg Intravenous

Indications