Solid Tumor, Adult Clinical Trial
Official title:
Safety Study of 89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
Verified date | March 2021 |
Source | Wuxi No. 4 People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients voluntarily signed informed consent; 2. Age 18-75, male or female; 3. Patients diagnosed with solid tumors confirmed by histopathology or cytology; 4. At least one measurable solid lesion has been examined by 18F-FDG PET/CT (RECIST1.1 standard); 5. Patients with biopsy-proven PD-L1 positive; 6. ECOG score = 0~1; Life expectancy of at least 3 months; 7. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects. Exclusion Criteria: 1. Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded; 2. Patients with systemic or locally severe infections (CTCAE = 2); 3. Patients with allergies or allergies to any component of the imaging agent or antibody; 4. Patients who cannot undergo PET/CT imaging; 5. Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia); 6. Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia; 7. Patients have significant QT/QTC interval prolongation during the screening period; 8. Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose; 9. Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered; 10. Patients need to receive other anti-tumor treatments during the trial period; 11. Previously received CD137 agonist or immune checkpoint blocking therapy; 12. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L; 13. HIV antibody positive, active hepatitis B/C, and TB positive; 14. Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol); 15. Patients with symptomatic ascites, pleural effusion, or hydropericardium; 16. Pregnant or lactating women, or planning to become pregnant or have children during this trial. |
Country | Name | City | State |
---|---|---|---|
China | Wuxi No. 4 People's Hospital | Wuxi | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Wuxi No. 4 People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Biodistribution of 89Zr-KN035 | The biodistribution of the tracer 89Zr-KN035 as assessed with 89Zr- KN035 PET scans. | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 |
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