This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
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.
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.