A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer
This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Male or female subjects aged 18 to 75 years (including 18 and 75 years).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.
• Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
• Subjects must submit tumor tissues for test.
• Life expectancy of ≥ 12 weeks.
• Subjects must have measurable disease according to RECIST (version 1.1).
• Adequate organ functions.
⁃ Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
⁃ Subjects are willing to follow study procedures