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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuxi No. 4 People's Hospital

Criteria

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.