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

Exclusion Criteria17

• Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
• Subjects with other malignancies within 5 years before the first dose.
• Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
• Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
• History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
• Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
• History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• Uncontrolled pleural effusion, ascites, or pericardial effusion.
• Have received ADCs with the same target or the same toxins.
• 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.
• Have undergone major surgery or severe trauma within 28 days before the first dose.
• Have received other clinical trial medications within 28 days before the first dose.
• Has previously received anti-cancer or live vaccines within 28 days before the first dose
• Have received systemic steroids or other immunosuppressive treatments within 14 days before the first dose.
• Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 days or 5 half-lives before the first dose.
• Pregnant or lactating female.
• Any disease or condition that, in the investigator's opinion, would compromise subject safety or interfere with study assessments.