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RecruitingNCT07308106Updated Jul 30, 2026

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 2 interventional study of SKB571 for injection in Non-small Lung Cancer, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Non-small Lung Cancer
03

In context

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    SKB571 monotherapy

    Drug: SKB571 for injection

Interventions

  • DrugSKB571 for injection

    SKB571 for injection is administered every 3 weeks(Q3W) .

06

What researchers measure

Primary outcomes

  1. AE

    Incidence and severity of adverse events (AEs)

    Time frame: Up to 24 months

  2. ORR

    Objective response rate (ORR) assessed by the investigator as per RECIST v1.1.

    Time frame: Up to 24 months

Secondary outcomes

  1. DCR

    Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)

    Time frame: Up to 24 months

  2. DOR

    Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.

    Time frame: Up to 24 months

  3. PFS

    Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

    Time frame: Up to 24 months

  4. OS

    Time from start of treatment to death due to any reason.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07308106
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 29, 2025
Start date
Apr 3, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jul 30, 2026

Study contacts

Yina Diao
Contact
diaoyina@kelun.com
028-67252634

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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