89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors

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.