A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

Summary

This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.

Timeline

Start

2019-05-30

Primary completion

2022-08-16

Completion

2022-10-27

Publications

• Li Q, Liu J, Zhang Q, Ouyang Q, Zhang Y, Liu Q, Sun T, Ye F, Zhang B, Xia S, Zhang B, Xu B. The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial. Nat Commun. 2024 Feb 3;15(1):1015. doi: 10.1038/s41467-024-45160-y.

Drugs

Indications