Clinical Trial · NCT03638804

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

Overview

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.

Sponsor

The First Affiliated Hospital of Soochow University

Phase

N/A

Contacts

Jianan Huang, PhD (PRINCIPAL_INVESTIGATOR)

Yicong Bian (CONTACT)

bianyicong@126.com

86 0512 6778 0467

Hua Zhang (CONTACT)

sdfyy8040@126.com

86 0512 6778 0040

Liyan Miao, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03638804

Drug / Compound

KN035

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Antibodies

Eligibility

Inclusion

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

Exclusion

Exclusion criteria not yet provided.