89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor, Adult
- Interventions
- Diagnostic Test: 89Zr-KN035
- Registration Number
- NCT03638804
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 89Zr-KN035 injection 89Zr-KN035 -
- Primary Outcome Measures
Name Time Method Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans 6 months
- Secondary Outcome Measures
Name Time Method Number of adverse events as assessed by CTCAE v4.03 6 months All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.
Number of changes in vital signs as accessed by CTCAE v4.03 6 months 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.
Number of changes in laboratory test results as accessed by CTCAE v4.03 6 months Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China