Clinical Trial · NCT04977128

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

Overview

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.

Sponsor

Sichuan Provincial People's Hospital

Phase

N/A

ClinicalTrials.gov

NCT04977128

Drug / Compound

KN035

Isotope(s):

Target(s):

PD-L1

Ligand Class: Small Proteins and Antibody Fragments

Chelator: DFO

Eligibility

Inclusion

At least one measurable solid lesion has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
Patients diagnosed with solid tumors confirmed by histopathology or cytology;
Patients with biopsy-proven PD-L1 positive;
ECOG score ≤ 0\~1; Life expectancy of at least 3 months;

Exclusion

Pregnant or lactating women, or planning to become pregnant or have children during this trial.
Patients with systemic or locally severe infections (CTCAE ≥ 2);
Patients have significant QT/QTC interval prolongation during the screening period;
Patients with symptomatic ascites, pleural effusion, or hydropericardium;
Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;
Patients need to receive other anti-tumor treatments during the trial period；
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);
Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);
Patients who cannot undergo PET/CT imaging;
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 diabetes who have a fasting blood glucose greater than 10 mmol/L;
Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;
HIV antibody positive, active hepatitis B/C, and TB positive;
Previously received CD137 agonist or immune checkpoint blocking therapy;
Patients with allergies or allergies to any component of the imaging agent or antibody;
Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;