A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities

NCT07308106 | Recruiting Phase 2

• 1 other identifier: SKB571-Ⅱ-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• DCR

  Up to 24 months

• DOR

  Up to 24 months

• PFS

  Up to 24 months

• OS

  Up to 24 months

Study Arms (1)

SKB571 monotherapy

EXPERIMENTAL

Drug: SKB571 for injection

Interventions

SKB571 for injection DRUG

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

SKB571 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants with known active central nervous system (CNS) metastasis, and/or carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.
• Participants with other malignant tumors within 3 years prior to the first dose.
• Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Presence of severe and/or uncontrolled concomitant diseases.
• Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.
• Clinically severe lung damage due to complications of lung disorder.
• Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.
• Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
• Active hepatitis B and hepatitis C.
• Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.
• Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.
• Serious infection within 4 weeks before the first dose.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yina Diao

CONTACT

028-67252634; diaoyina@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: April 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CN (1)