A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

Exclusion Criteria

• •1. Known hypersensitivity to recombinant anti-PD-1 all human monoclonal antibody drugs and its components, or known allergy to any paclitaxel or albumin bound paclitaxel component; A history of uncontrollable allergic asthma;
• •2. Previously diagnosed other malignancies within 3 years prior to screening, except for adequately treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, thyroid cancer or cured in situ carcinoma, such as cervical carcinoma in situ;
• •3. Patients with active autoimmune disease or history of autoimmune disease, except for well-controlled type I diabetes, well-controlled hypothyroidism only requiring hormone replacement therapy, skin disease that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or patients whose diseases are not expected to recur in the absence of external triggers;
• •4. Patients with a history of primary immunodeficiency;
• •5. Patients with serious cardiovascular diseases, such as heart failure rated as grade 2 or above by the New York Heart Association (NYHA) classification, myocardial infarction within 3 months before screening, poorly controlled arrhythmia or unstable angina pectoris, or serious arterial/venous thrombotic events (such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism, etc.) within 3 months prior to screening;
• •6. Interstitial lung disease requiring systemic therapy of glucocorticoid;
• •7. Known untreated central nervous system (CNS) metastasis and meningeal metastasis, or treated but still symptomatic CNS metastasis and meningeal metastasis; However, asymptomatic untreated CNS metastasis and meningeal metastasis, and treated and symptomatically stable CNS metastasis and meningeal metastasis can be included.
• •8. Have received any other antibodies/drugs that act on T-cell co-stimulation or checkpoint pathway (including but not limited to PD-1, PD-L1, PD-L2, CTLA-4, OX40, c137 inhibitors, etc.);
• •9. Major surgery within 28 days before the first dose of study treatment, radiotherapy within 14 days before the first dose of study treatment, or use of radiation agents (strontium, or samarium, etc.) within 56 days before the first administration;
• •10. Systemic antitumor therapy within 14 days before the first administration;
• •11. Patients who have received live attenuated vaccine within 28 days before the first administration or planned to receive it during the study period.
• •12. Any Chinese patent medicine treatment with an approved antitumor indication by NMPA or Chinese herbal medicine treatment for the purpose of antitumor which is clearly recorded in the medical record within 14 days before the first administration;
• •13. Active tuberculosis;
• •14. Active infection requiring intravenous infusion treatment within 14 days before the first administration;
• •15. Received glucocorticoid (prednisone \> 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive treatment for some conditions within 14 days before the first administration;
• •16. Those who have received other test drugs within 28 days before the first administration;
• •17. Human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-AB) positive; Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, with hepatitis B virus quantitative detection value \> upper limit of normal (ULN) value of the detected center; Hepatitis C antibody (HCV-Ab) positive, with hepatitis B virus RNA quantification \> ULN value of the detected center.
• •18. Pregnant or lactating women; Or positive test for blood pregnancy during screening;
• •19. Other situations that may increase the risks related to the study medication, interfere with the interpretation of the study results, affect compliance of the trial, etc. are determined by the investigator to be not suitable for the trial.