About this trial
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent and follow the requirements of the protocol;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
ECOG 0 or 1;
Disqualifiers
ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
Palliative radiotherapy within 2 weeks before the first dose;
Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
Use of an immunomodulatory drug within 14 days before the first dose of study drug;
Trial design
Treatments tested in this trial
- BL-B01D1
- PD-1 Monoclonal Antibody
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator