An interventional study of 89Zr-KN035 in Solid Tumor, Adult, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Diagnostic
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria(main):
Diagnostic Test: 89Zr-KN035
Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
Time frame: 6 months
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.
Time frame: 6 months
Number of changes in laboratory test results as accessed by CTCAE v4.03
Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.
Time frame: 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.
Time frame: 6 months
Maximum serum concentration of 89Zr-KN035 (Cmax)
Blood samples will be collected and assessed by timepoints.
Time frame: 6 months
Time to Maximum Concentration of 89Zr-KN035 (Tmax)
Blood samples will be collected and assessed by timepoints.
Time frame: 6 months
Calculation of radiation dosimetry of 89Zr-KN035
Time frame: 6 months
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University