drugset / Trial / NCT04881929

Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

NCT04881929

Phase 2 Unknown 30 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

Timeline

Start
2021-08-09
Primary completion
2022-11-15
Completion
2023-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject KN026 Monoclonal antibody 30 mg/kg Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications