A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged 18-75 years at the time of signing the informed consent form 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors . 3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1. 4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1. 5. Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months. 6. Subjects who have adequate organ function. 7. Subjects who have recovered from all toxicities due to prior therapy . 8. Male and female subjects must agree to use highly effective contraception methods during the study treatment. 9. Subjects who voluntarily sign the informed consent form. Exclusion Criteria: 1. Subjects with known active or untreated central nervous system (CNS) metastases. 2. Subjects with other malignant tumors within 3 years prior to the first dose. 3. Subjects with history of major cardiov