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

A Phase Ib/II Study to Evaluate Efficacy, Safety and Tolerability of KN046 Monotherapy or in Combination With Nab-paclitaxel in Subjects With Triple-negative Breast Cancer

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.

Inclusion Criteria:

• Signed informed consent;
• Age of 18 or above;
• Histology confirmed locally advanced unresectable or metastatic triple-negative breaset cancer;
• (KN046 monotherapy) failed at least one prior anthracycline and taxane containing systemic treatment, (KN046 plus nab-paclitaxel) systemic treatment naive;
• Measurable disease at baseline;
• ECOG 0-1;
• Adequate organ functions.

Exclusion Criteria:

• Untreated active CNS metastasis or leptomeningeal metastasis;
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment;
• Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; History of uncontrolled intercurrent illness; Known severe hypersensitivity reactions to antibody drug.