TheranosticTrials.org

Clinical Trial · NCT04897763

Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC

Overview

The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.

Sponsor

Institut Cancerologie de l'Ouest

Phase

Early Phase 1

Contacts

Caroline ROUSSEAU, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT04897763

Drug / Compound

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Negative sterile Urine cytobacteriological testing at baseline (T0).
  • Histologically-confirmed pTa Grade 3 or pT1 Grade 3 bladder cancer patients relapsing without muscle invasion.
  • Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors.
  • Consent to use a contraception method for at least 30 days after administration of 89Zr-girentuximab.
  • Patient has valid health insurance.
  • Performance Status: 0 or 1.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion

  • Patients suffering from a bladder cancer at stage pT2, pT3 or pT4
  • Pregnant or likely to be pregnant or nursing patient.
  • Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
  • Patients with known human immunodeficiency viruses (HIV), Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) infections,
  • Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of 89Zr-girentuximab administration
  • Known hypersensitivity to girentuximab.
  • Patient with urinary incontinence.
  • Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab
  • Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient; as judged by the investigator
  • Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab