A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. 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.
• Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
• Participants with histologically or cytologically confirmed NSCLC.
• Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
• Life expectancy ≥ 3 months as assessed by the investigator.
• Adequate organ and bone marrow function.
• Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
• Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.