This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled KN035 (89Zr-KN035) PET Imaging in patients with PD-L1 positive solid tumors.
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-KN035 and will undergo PET/CT scanning to determine uptake of 89Zr-KN035 in tumor lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)
Wuxi No. 4 People's Hospital
Wuxi, Jiangsu, China
RECRUITINGTo evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients
Safety will be assessed by evaluation of incidence of adverse events
Time frame: 1 year
Biodistribution of 89Zr-KN035
The biodistribution of the tracer 89Zr-KN035 as assessed with 89Zr- KN035 PET scans.
Time frame: 1 year
Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
Time frame: 1 year
Evaluation of immunotherapy efficacy
The correlation between the 89Zr-KN035 tumor uptake (Standardized uptake value SUV ) and response to therapy by performing 89Zr-KN035 scan before PD1 therapy, related to CT/MRI response according to RECIST1.1 criteria.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.