HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy

Summary

Primary objective: To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors, RECIST 1.1); Secondary objectives: 1. To evaluate other efficacy variables, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and overall survival (OS), for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of HR positive, HER2 negative advanced breast cancer; 2. To evaluate the safety of EOC202 combined with albumin-bound paclitaxel; 3. To evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel; 4. To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10). Exploratory objectives: To explore the correlation of baseline soluble MHC-II ligands in blood (lymphocyte activation gene-3 (Lag-3) and fibrin related antigen (FGL-1)) with safety, efficacy, PD and anti-drug antibody (ADA) in subjects in EOC202 combined with albumin-bound paclitaxel group.

Timeline

Start

2022-04

Primary completion

2023-03

Completion

2025-05

Drugs

Indications