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| Name | Class |
|---|---|
| MITRO Biotech Co., Ltd. | UNKNOWN |
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This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.
The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr-KN035 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-KN035 | Diagnostic Test | Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as assessed by CTCAE v4.03 | All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not. | 6 months |
| Number of changes in laboratory test results as accessed by CTCAE v4.03 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration of 89Zr-KN035 (Cmax) | Blood samples will be collected and assessed by timepoints. | 6 months |
| Time to Maximum Concentration of 89Zr-KN035 (Tmax) | Blood samples will be collected and assessed by timepoints. |
Inclusion Criteria (main):
Exclusion Criteria(main):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhang | Contact | 86 0512 6778 0040 | sdfyy8040@126.com | |
| Yicong Bian | Contact | 86 0512 6778 0467 | bianyicong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Jianan Huang, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.
| 6 months |
| Number of changes in vital signs as accessed by CTCAE v4.03 | Vital signs (heart rate, respiratory rate, blood pressures and body temperature) data will be collected by time. Significant changes will be assessed by CTCAE v4.03. | 6 months |
| 6 months |
| Calculation of radiation dosimetry of 89Zr-KN035 | 6 months |