This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
Male or female participants between 18 and 75 years old.
Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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).
Single group
SKB500
DrugThe administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W.
Evaluate the incidence of adverse events (AEs)
Evaluate the incidence of serious adverse events (SAEs)
Evaluate the incidence of treatment related adverse events (TRAEs)
Evaluate the incidence of dose-limiting toxicities (DLTs)
Investigate the antitumor activity of SKB500
To evaluate the Tmax of SKB500
To evaluate the Cmax of SKB500
To evaluate the Cmin of SKB500
To evaluate the relationship between the biomarker and the antitumor activity
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