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Clinical Trials in China / NCT07230405
Recruiting Phase 2

A Phase II Study of SKB571 in Patients With Lung Cancer

NCT07230405 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Phase
Phase 2
Started
2026-01-19
Last updated
2026-05-12

Condition(s) studied

Lung Cancer (Non-Small Cell)

Investigational drug(s) / intervention(s)

SKB571 for injection →

SKB571 for injection: SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 NSCLC . 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 ≥ 12 weeks. 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 cardiovascular, cerebrovascular, or thromboembolic disease. 4. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C. 5. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage. 6. Subjects with known allergy or hypersensitivity to SKB571 or its excipients. 7. Subjects with clinically severe lung injuries due to pulmonary complications. 8. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD 9. Subjects with major surgery within 28 days prior to the first dose. 10. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study. 11. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer. 12. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment. 13. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment. 14. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \> 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. 15. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sun Yat-Sen University Cancer Center Guangzhou China Not Yet Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07230405 on ClinicalTrials.gov ↗ ← All trials in China