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

Inclusion Criteria:

1. Male or female participants between 18 and 75 years old.

2. Histologically or cytologically confirmed advanced solid tumors for which standardtreatment either does not exist or has proven ineffective or intolerable.

3. Subjects should ideally provide a tumor tissue sample for biomarker testing duringthe screening period.

4. Has at least 1 measurable lesion according to Response Evaluation Criteria in SolidTumors (RECIST) Version 1.1

5. ECOG performance status score of 0 or 1.

6. Expected survival of at least 12 weeks.

7. Has adequate hematopoietic, renal and hepatic functions.

8. Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.

9. Male and female subjects must agree to use highly effective contraceptive methodsthroughout the study.

10. Subjects must voluntarily enter the study, sign the informed consent form, and beable to comply with the visits and procedures.

Exclusion Criteria:

1. Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningealmetastases, 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 thesubject's participation in the study.

4. Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiencyvirus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).

5. History of allergy to any component of SKB500 or history of severe hypersensitivityreactions to other monoclonal antibodies.

6. Subjects with a history of interstitial lung disease, non-infectious pneumonia, orother pulmonary diseases significantly affecting lung function.

7. History of allogeneic organ transplantation or hematopoietic stem celltransplantation.

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 Chinesemedicine preparations within 14 days or 5 half-lives before the first dose; havereceived any immunotherapy, large molecule anticancer drug treatment, or more than 30% bone marrow radiation or extensive radiotherapy within 28 days before the firstdose.

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 firstdose

14. Have received systemic steroids or other immunosuppressive treatments within 14 daysbefore the first dose.

15. Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 daysor 5 half-lives before the first dose.

16. Pregnant or lactating female.

17. Any disease or condition that, in the investigator's opinion, would compromisesubject safety or interfere with study assessments.