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Clinical Trials/NCT07308106
NCT07308106
Recruiting
Phase 2

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

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.1 site in 1 country60 target enrollmentStarted: April 3, 2026Last updated:
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InterventionsSKB571 for injection
DrugsSKB571 for injection

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
ORR
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •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.

Exclusion Criteria

  • •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
  • •Known active pulmonary tuberculosis.
  • •Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.

Arms & Interventions

SKB571 monotherapy

Experimental

Intervention: SKB571 for injection (Drug)

Outcomes

Primary Outcomes

ORR

Time Frame: Up to 24 months

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

AE

Time Frame: Up to 24 months

Incidence and severity of adverse events (AEs)

Secondary Outcomes

  • DCR(Up to 24 months)
  • DOR(Up to 24 months)
  • OS(Up to 24 months)
  • PFS(Up to 24 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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