A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

Exclusion Criteria

• •1. Received biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs such as tegafur/gimeracil/oteracil (S-1) or capecitabine, or oral endocrine therapy, or palliative radiotherapy within 2 weeks before the first dose);
• •2. History of severe heart disease;
• •3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia;
• •4. Active autoimmune or inflammatory diseases;
• •5. Diagnosis of other malignancies within 2 years prior to the first dose;
• •6. Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg) despite the use of two antihypertensive medications;
• •7. Poorly controlled blood glucose (defined as: a) two fasting blood glucose levels \>10 mmol/L, or b) glycated hemoglobin level exceeding 8%), or concurrent diabetic gangrene;
• •8. History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;
• •9. Concurrent pulmonary disease leading to clinically significant respiratory impairment;
• •10. Unstable deep vein thrombosis, arterial thrombosis, pulmonary embolism, or other thrombotic events requiring therapeutic intervention within 6 months before screening (excluding catheter-related thrombosis);
• •11. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
• •12. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
• •13. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1;
• •14. Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels, unless the investigator deems it does not affect the patient's eligibility for treatment;
• •15. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• •16. Cumulative anthracycline dose \>360 mg/m² in prior (neo)adjuvant anthracycline therapy;
• •17. Positive for human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
• •18. Severe infection (CTCAE \> Grade 2) within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose;
• •19. Participation in another clinical trial within 4 weeks before the first dose (calculated from the last dose date);
• •20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.