Safety and Efficacy of KN046 in Combination with KN026 in Patients with Advanced HER2-Positive Breast Cancer: A Phase II Trial.

ABSTRACT:

Purpose

In this study, we report the results from a phase II trial assessing the safety and efficacy of KN046 in combination with KN026 in patients with HER2-positive metastatic breast cancer, who had progressed after prior anti-HER2 combination therapies.

Patients and methods

Female patients with metastatic HER2-positive breast cancer, who were previously treated with at least one line of HER2-targeted combination therapy, were enrolled from multiple academic hospitals in China to receive KN046 (i.v. 5 mg/kg every 3 weeks) plus KN026 (i.v. 30 mg/kg every 3 weeks) until progression, unacceptable toxicities, or patient withdrawal. Efficacy was evaluated every 6 weeks per RECIST 1.1. The primary endpoint was objective response rate.

Results

A total of 36 patients with t

SUBMITTER: Liu J 

PROVIDER: S-EPMC12163597 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature