Clinical trial NCT03638804: 89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors
Official title: 89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: 89Zr
PD-L1
KN035
PET
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: MITRO Biotech Co., Ltd.
First posted: 2018-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
timeFrame: 6 months
Secondary outcomes:
measure: Number of adverse events as assessed by CTCAE v4.03
timeFrame: 6 months
measure: Number of changes in laboratory test results as accessed by CTCAE v4.03
timeFrame: 6 months
measure: Number of changes in vital signs as accessed by CTCAE v4.03
timeFrame: 6 months
Other outcomes:
measure: Maximum serum concentration of 89Zr-KN035 (Cmax)
timeFrame: 6 months
measure: Time to Maximum Concentration of 89Zr-KN035 (Tmax)
timeFrame: 6 months
measure: Calculation of radiation dosimetry of 89Zr-KN035
timeFrame: 6 months
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Soochow University
name: Jianan Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: