SKB571 as a single treatment for advanced or metastatic non-small cell lung cancer with MET abnormalities

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

This trial will try SKB571 alone in adults with locally advanced or metastatic non-small cell lung cancer that has MET abnormalities and has progressed after standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT07308106 on ClinicalTrials.gov

What this trial studies

This Phase II, interventional trial administers SKB571 as monotherapy to adults with locally advanced or metastatic NSCLC who have documented MET abnormalities and disease progression after standard therapy. Participants receive SKB571 until radiographic progression, intolerable toxicity, withdrawal, or other protocol-specified discontinuation, with tumor responses measured per RECIST v1.1. Key eligibility includes age 18–75, ECOG performance status 0–1, measurable disease, and adequate organ function. Safety, tolerability, and anti-tumor activity will be monitored at the single participating site in Shanghai.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed locally advanced or metastatic NSCLC harboring MET abnormalities, measurable disease, ECOG 0–1, and progression after standard therapy are ideal candidates.

Not a fit: Patients whose tumors do not have MET abnormalities or who have active, untreated CNS metastases are unlikely to benefit from this SKB571 monotherapy.

Why it matters

Potential benefit: If effective, SKB571 could shrink tumors or slow disease progression in MET-driven NSCLC and provide an additional targeted option for patients who have exhausted standard therapies.

How similar studies have performed: Other MET-targeted therapies have produced meaningful responses in MET-driven NSCLC, but SKB571 is an investigational agent that has not yet been proven in large clinical trials.

Eligibility criteria

Inclusion Criteria:

1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
2. Participants with histologically or cytologically confirmed NSCLC.
3. Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.
4. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.
6. Life expectancy ≥ 3 months as assessed by the investigator.
7. Adequate organ and bone marrow function.
8. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
9. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion Criteria:

1. Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
2. Participants with other malignant tumors within 3 years prior to the first dose.
3. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
4. Presence of severe and/or uncontrolled concomitant diseases.
5. Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.
6. Clinically severe lung damage due to complications of lung disorder.
7. Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.
8. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1.
9. Known active pulmonary tuberculosis.
10. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
11. Active hepatitis B and hepatitis C.
12. Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
13. Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.
14. Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.
15. Serious infection within 4 weeks before the first dose.
16. Participants who have received systemic corticosteroid therapy with \> 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before the first dose of study treatment.
17. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.
18. Pregnant or breastfeeding women.
19. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors.
20. Any condition that, in the investigator's opinion, interferes with the evaluation of study treatment, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yina Diao

Conditions Non-small Lung Cancer