Actively Recruiting
A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 75 years old
- Histologically or cytologically confirmed Non-Small Cell Lung Cancer
- Locally advanced or metastatic NSCLC with MET abnormalities that progressed after standard therapy
- At least one measurable tumor lesion as per RECIST v1.1
- ECOG performance status of 0 or 1 within 7 days before first dose
- Life expectancy of 3 months or more
- Adequate organ and bone marrow function
- Agreement to use effective contraception during treatment
- Ability and willingness to sign informed consent and comply with study procedures
You will not qualify if you...
- Known active central nervous system metastasis, carcinomatous meningitis, brainstem metastasis, spinal cord metastasis, or spinal cord compression
- Other malignant tumors within 3 years prior to first dose
- Presence of significant cardiovascular or cerebrovascular diseases or risk factors
- Severe or uncontrolled concomitant diseases
- History of interstitial lung disease or non-infectious pneumonitis
- Severe lung damage from lung disorders
- Risk of esophagotracheal or esophagopleural fistula, or tumor invasion/compression of vital organs or blood vessels
- Toxicity from prior anti-tumor therapy not recovered to Grade 1 or less
- Known active pulmonary tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplant
- Active hepatitis B or C infection
- Positive HIV test or AIDS history, or active syphilis infection
- Allergy or severe hypersensitivity to SKB571 or similar monoclonal antibodies
- Major surgery within 4 weeks before first dose or planned during study
- Serious infection within 4 weeks before first dose
- Systemic corticosteroids over 10 mg/day prednisone or immunosuppressive drugs within 2 weeks before first dose
- Live vaccine within 30 days before first dose or planned during study
- Pregnant or breastfeeding women
- Presence of local or systemic diseases caused by non-malignant tumors or symptoms secondary to tumors
- Any condition interfering with safety, treatment evaluation, or study interpretation as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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