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

Study Overview
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Brief Summary
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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
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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.

Official Title
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89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Diagnostic Test: 89Zr-KN035


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (main): Patients voluntarily signed informed consent; Age 18-75, male or female; Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology; Patients with biopsy-proven PD-L1 positive; ECOG score ≤ 0 1; Life expectancy of at least 3 months; 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): 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. Patients with systemic or locally severe infections (CTCAE ≥ 2); Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot undergo PET/CT imaging; Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia); Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia; Patients have significant QT/QTC interval prolongation during the screening period; Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose; Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered; Previously received CD137 agonist or immune checkpoint blocking therapy; Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L; HIV antibody positive, active hepatitis B/C, and TB positive; 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); Patients with symptomatic ascites, pleural effusion, or hydropericardium; Pregnant or lactating women, or planning to become pregnant or have children during this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-KN035 injection<br> | Diagnostic Test: 89Zr-KN035<br>* Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events as assessed by CTCAE v4.03 | All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not. | 6 months | 
| Number of changes in laboratory test results as accessed by CTCAE v4.03 | Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03. | 6 months | 
| Number of changes in vital signs as accessed by CTCAE v4.03 | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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89Zr, PD-L1, KN035, PET