Actively Recruiting
A Phase II Study of SKB571 in Patients With Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-12
295
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase II Study of SKB571 in Patients With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of consent
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks as assessed by the investigator
- Adequate organ function
- Recovery from all toxicities related to prior therapy
- Agreement to use highly effective contraception methods during study treatment
- Voluntary signing of the informed consent form
You will not qualify if you...
- Known active or untreated central nervous system (CNS) metastases
- Other malignant tumors within 3 years prior to first dose
- History of major cardiovascular, cerebrovascular, or thromboembolic disease
- HIV infection or active viral hepatitis B or C
- Uncontrolled pleural, pericardial, or ascites effusions requiring repeated drainage
- Known allergy or hypersensitivity to SKB571 or its ingredients
- Clinically severe lung injuries from pulmonary complications
- History or current noninfectious pneumonitis or interstitial lung disease requiring steroids
- Major surgery within 28 days prior to first dose
- Receipt of live vaccines within 30 days prior to first dose or planned during study
- Use of strong CYP3A4 or BCRP inhibitors or inducers within 2 weeks prior to first dose or 5 drug half-lives
- Chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to first dose
- Active infection requiring systemic anti-infective treatment within 14 days prior to first dose
- Systemic corticosteroids over 10 mg/day prednisone or equivalent or immunosuppressive therapy within 14 days prior to first dose
- Any condition interfering with safety assessment or study interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
2
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
X
Xin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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