89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors

Soochow University

Status: Unknown

Conditions: Solid Tumor, Adult

Treatments: Diagnostic Test: 89Zr-KN035

Study type: Interventional

Funder types: Other

Identifiers

NCT03638804

AMS-2017-007-a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

89Zr-KN035 injection

Experimental group

Treatment:

Diagnostic Test: 89Zr-KN035