A Phase II Study of SKB571 in Patients With Lung Cancer (NCT07230405) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study of SKB571 in Patients With Lung Cancer
China190 participantsStarted 2026-01-19
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subjects with known active or untreated central nervous system (CNS) metastases.
✕. Subjects with other malignant tumors within 3 years prior to the first dose.
✕. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
✕. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.