A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally 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

The aim of the 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. 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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Lung Cancer
• Intervention / Treatment: Drug: SKB571 for injection

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yina Diao; Phone Number: 028-67252634; Email: diaoyina@kelun.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Pulmonary Hospital
    • Contact: Shengxiang Ren; Phone Number: 021-65115006-3051; Email: harry_ren@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SKB571 monotherapy	Drug: SKB571 for injection; SKB571 for injection is administered every 3 weeks(Q3W) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	Incidence and severity of adverse events (AEs)	Up to 24 months
ORR	Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.	Up to 24 months
DOR	Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.	Up to 24 months
OS	Time from start of treatment to death due to any reason.	Up to 24 months
DCR	Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)	Up to 24 months

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: SKB571-Ⅱ-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No