SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Exclusion Criteria

• •Subjects who meet any of the following criteria will be excluded:
• •1. Patients with a history of central nervous system (CNS) metastases or current CNS metastases;
• •2. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
• •3. Patients with Gilbert's disease;
• •4. Patients who have received prior TROP2-targeted therapy;
• •5. Patients who have received live vaccines within 30 days prior to the first dose;
• •6. Patients who required the treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment (strong inhibitors or inducers of CYP3A4 are not allowed in this study, and representative drugs of strong CYP3A4 inhibitors or inducers are listed in the Annex). Patients who received continued high dose of systemic corticosteroids within 2 weeks prior to the first dose (low-dose corticosteroids, such as ≤ 10 mg daily prednisone or equivalent, are allowed if the dose is stable for 4 weeks);
• •7. Patients who have received any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biological therapy or other drugs within 4 weeks prior to the first dose of study treatment or within 5 half-lives of the drug used in the previous period (whichever is shorter), or received treatment with traditional Chinese medicine preparations for approved anti-tumor indications 2 weeks prior to the first dose of study treatment, or received major surgeries 4 weeks prior to the first dose of study treatment;
• •8. With concomitant infections requiring systemic antibiotic therapy within 1 week prior to the first dose of study treatment;
• •9. Presence of any serious and/or uncontrolled comorbidities that prevent the patient from participating in the study, such as:
• •1. Impaired cardiac function, including any of the following: (not necessarily all of the following):
• •aa) Corrected QT interval (QTcF) between ventricular depolarization to repolarization \> 480 ms at baseline; ab) Left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography (ECHO) ;
• •2. Other clinically significant heart diseases, including any of the following known medical history:
• •ba) Angina pectoris; bb) Congestive cardiac failure; bc) Myocardial infarction;
• •3. Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;
• •4. Patients with current or previous active chronic inflammatory bowel disease or intestinal obstruction or gastrointestinal (GI) perforation;
• •5. Uncontrolled hypertension (systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 100 mm Hg), with a history of unstable hypertension, or with a history of poor compliance with antihypertensive treatment;
• •6. Uncontrolled diabetes (fasting glucose ≥ 10 mmol/L and/or glycated hemoglobin (HbA1c) ≥ 8%);
• •10. Active hepatitis B (hepatitis B surface antigen positive, and HBV-DNA above 500 IU/ml or 1x ULN, whichever is higher) or hepatitis C (hepatitis C antibody positive, and HCV-RNA above 1x ULN); with known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test;
• •11. History of serious drug allergy, with known allergy to macromolecular protein preparations or any component of the study drug formulation;
• •12. Pregnant or lactating women; or patients of childbearing potential (male or female) who cannot use effective medical contraception during the study treatment period and for 6 months after the end of the dosing period (see Annex for specific contraceptive measures);
• •13. During the screening process prior to the first dose, the condition deteriorated rapidly, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy;
• •14. Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.