A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer
This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
• Subjects aged 18-75 years at the time of signing the informed consent form
• Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
• Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
• Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
• Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.
• Subjects who have adequate organ function.
• Subjects who have recovered from all toxicities due to prior therapy .
• Male and female subjects must agree to use highly effective contraception methods during the study treatment.
• Subjects who voluntarily sign the informed consent form.