XCancer

Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN

Description:

Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. 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 tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.

Sponsor:

Nantes University Hospital

Phase:

N/A

Contacts:

Astrid GARREAU (CONTACT)

astrid.garreau@chu-nantes.fr

+33253482840

Clément BAILLY (CONTACT)

clement.bailly@chu-nantes.fr

+33240084136

Government Study Link:

NCT06735560 - Click here to see study on

ClinicalTrials.gov

TLX250

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

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DOTA
Inclusion
  • Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
Exclusion
  • Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
  • Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.