AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Inclusion criteria

• Voluntarily sign a written informed consent form.
• Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
• Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
• Suitable for monotherapy with taxane-based agents.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate organ function.

Exclusion criteria

• Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
• History of other malignancies within the past 5 years.
• Active autoimmune disease requiring systemic treatment within the past 2 years.
• Pregnant or breastfeeding women.
• Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
• Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
• Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
• Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.