Phase II test of SKB571 for advanced non-small cell lung cancer

A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer

This study will test SKB571 given alone in adults with advanced non-small cell lung cancer to see if it is safe and can shrink tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 295 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 2 sites (Guangzhou and 1 other locations)
• Trial ID: NCT07230405 on ClinicalTrials.gov

What this trial studies

This is a multicenter Phase II trial of SKB571 monotherapy in adults with locally advanced or metastatic non-small cell lung cancer. Participants who meet eligibility will receive SKB571 until radiographic disease progression, intolerable toxicity, withdrawal, or other protocol-specified discontinuation. Key eligibility includes age 18–75, ECOG 0–1, at least one measurable lesion per RECIST v1.1, and adequate organ function. The study is sponsored by Sichuan Kelun‑Biotech and is conducted at cancer centers in China.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced or metastatic non-small cell lung cancer, ECOG performance status 0–1, at least one measurable lesion, and adequate organ function are the intended candidates.

Not a fit: Patients with active or untreated central nervous system metastases, recent other malignancies, poor performance status, significant organ dysfunction, or those outside the age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, SKB571 could offer a new treatment option that helps control tumor growth in advanced non-small cell lung cancer.

How similar studies have performed: Single-agent experimental therapies have shown benefit in selected NSCLC groups, but SKB571 appears to be investigational with limited prior clinical data reported.

Eligibility criteria

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.

Where this trial is running

Guangzhou and 1 other locations

• Sun Yat-Sen University Cancer Center — Guangzhou, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Xin Li

Conditions Lung Cancer