Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Provided written informed consent.

Patients aged ≥ 18 years.

- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.

Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.

Disqualifiers

Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.

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.

Radioembolization within 3 months prior to inclusion.

Trial design

Treatments tested in this trial

  • 89Zr-TLX250 PET/CT

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

2
CHU de Nantes Nantes France
AP-HP - Site de Beaujon Paris France

Sponsors and collaborators

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov