A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •1. Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
• •2. Subjects with other malignancies within 5 years before the first dose.
• •3. Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
• •4. Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
• •5. History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
• •6. Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
• •7. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• •8. Uncontrolled pleural effusion, ascites, or pericardial effusion.
• •9. Have received ADCs with the same target or the same toxins.
• •10. Have received chemotherapy, small molecule targeted therapy, and traditional Chinese medicine preparations within 14 days or 5 half-lives before the first dose; have received any immunotherapy, large molecule anticancer drug treatment, or more than 30% bone marrow radiation or extensive radiotherapy within 28 days before the first dose.
• •11. Have undergone major surgery or severe trauma within 28 days before the first dose.
• •12. Have received other clinical trial medications within 28 days before the first dose.
• •13. Has previously received anti-cancer or live vaccines within 28 days before the first dose
• •14. Have received systemic steroids or other immunosuppressive treatments within 14 days before the first dose.
• •15. Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 days or 5 half-lives before the first dose.
• •16. Pregnant or lactating female.
• •17. Any disease or condition that, in the investigator's opinion, would compromise subject safety or interfere with study assessments.