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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:89Zr-KN035 injection | Experimental | Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-KN035 | Drug | Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients | Safety will be assessed by evaluation of incidence of adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of 89Zr-KN035 | The biodistribution of the tracer 89Zr-KN035 as assessed with 89Zr- KN035 PET scans. | 1 year |
| Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuxi No. 4 People's Hospital | Recruiting | Wuxi | Jiangsu | 214062 | China |
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Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
| 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. | 1 year |