Solid Tumor, Adult
Conditions
Keywords
89Zr, PD-L1, KN035, PET
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.
Interventions
DIAGNOSTIC_TEST89Zr-KN035
Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.
Sponsors
MITRO Biotech Co., Ltd.
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
(main): 1. Patients voluntarily signed informed consent; 2. Age 18-75, male or female; 3. Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology; 4. Patients with biopsy-proven PD-L1 positive; 5. ECOG score ≤ 0\ 1; Life expectancy of at least 3 months; 6. 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
(main): 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. Previously received CD137 agonist or immune checkpoint blocking therapy; 11. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L; 12. HIV antibody positive, active hepatitis B/C, and TB positive; 13. 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); 14. Patients with symptomatic ascites, pleural effusion, or hydropericardium; 15. Pregnant or lactating women, or planning to become pregnant or have children during this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration of 89Zr-KN035 (Tmax) | 6 months | Blood samples will be collected and assessed by timepoints. |
| Calculation of radiation dosimetry of 89Zr-KN035 | 6 months | — |
| Maximum serum concentration of 89Zr-KN035 (Cmax) | 6 months | Blood samples will be collected and assessed by timepoints. |
Countries
China
Contacts
Primary ContactHua Zhang
Backup ContactYicong Bian
Outcome results
None listed