A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors
Trial Parameters
Brief Summary
This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Male or female participants between 18 and 75 years old. 2. Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable. 3. Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period. 4. Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (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 methods throughout the study. 10. Subjects must voluntarily enter the study, sign the informed consent form, and be able to comply with the visits and procedures. Exclusion Criteria: 1. Subjects with known active CNS metastases, carcinomat