Taizhou Yibaikang Pharmaceutical Technology Co Ltd

Main purpose: To evaluate the progression-free survival (PFS) of EOC202 combined with nab-paclitaxel compared with nab-paclitaxel alone in patients with HR-positive, HER2-negative advanced breast cancer (RECIST 1.1); Secondary purpose: 1) To evaluate other efficacy indicators of EOC202 combined with nab-paclitaxel compared with nab-paclitaxel alone in the treatment of HR-positive, HER2-negative advanced breast cancer, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and overall survival (OS); 2) To evaluate the safety of EOC202 combined with nab-paclitaxel; 3) To evaluate the immunogenicity of EOC202 combined with nab-paclitaxel; 4) To evaluate the changes in pharmacodynamic (PD) markers (Interferon-γ, CXCL-10). Exploratory purpose: To explore the correlation between baseline blood levels of soluble MHC-II ligands (lymphocyte activation gene-3 (Lag-3) and fibrinogen-related antigen (FGL-1)) and safety, efficacy, PD and anti-drug antibodies (ADA) in subjects in the EOC202 combined with albumin-paclitaxel group.

To evaluate the safety and tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity characteristics, preliminary antitumor efficacy of subcutaneous injection of EOC202 combined with intravenous paclitaxel in Chinese patients with metastatic breast cancer, and to explore the correlation between the immunogenicity and pharmacodynamics of EOC202.