Abstract

This early Phase I pilot open-label feasibility study evaluates the safety, tolerability, radiation dosimetry, and imaging properties of ⁸⁹Zr-labeled girentuximab, a radiopharmaceutical targeting the carbonic anhydrase IX (CAIX) antigen, for PET/CT imaging in patients with non-muscle invasive bladder cancer (NMIBC). The study enrolled 6 patients with NMIBC to assess the diagnostic potential of this novel imaging agent. ⁸⁹Zr-girentuximab enables precise visualization of CAIX-expressing tumor cells, offering valuable insights for patient selection and treatment planning in targeted alpha therapy approaches. This monocentric, prospective study was conducted at Institut de Cancérologie de l’Ouest (ICO) in collaboration with Atonco, contributing to the development of theranostic strategies combining diagnostic imaging with therapeutic applications using the anti-CAIX antibody girentuximab.

Publication Information

Source: ClinicalTrials.gov

Trial Registration Date: May 21, 2021

Study Completion Date: September 26, 2022

Trial ID: NCT04897763

Study Status: COMPLETED

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT04897763

Authors

Sponsor: Institut de Cancérologie de l’Ouest (ICO)

Collaborator: Atonco

Principal Investigator: Caroline Rousseau, MD, PhD

Institutional Affiliation: Institut de Cancérologie de l’Ouest, Saint-Herblain (44805), France

Phase: Early Phase I (Diagnostic)

Actual Enrollment: 6 patients

Study Timeline: October 1, 2021 – September 26, 2022

Study Design: Monocentric, open-label, prospective, single-arm