This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
Female patients aged 18 to 75 years;
Expected survival time ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
Use of immunomodulators within 14 days before the first study drug dose;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator