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

NCT06735560 | Recruiting

• 1 other identifier: RC23_0453
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neuroendocrine Tumors; Hepatocellular Carcinoma (HCC); Intrahepatic Cholangiocarcinoma (Icc)

Keywords

immunoPET; CAIX; GEP-NEN; ICC; HCC

Outcome Measures

Primary Outcomes (2)

• Tumor targeting of 89Zr-TLX250 PET

  Number of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.

  Day 5

• Tumor targeting of 89Zr-TLX250 PET

  Location of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.

  Day 5

Secondary Outcomes (10)

• Evaluation of tolerability

  Hour 2

• Evaluation of tolerability

  Day 8

• Diagnostic efficacy

  Month 3

• Diagnostic efficacy

  Month 3

• Assessment of tumor uptake

  Day 8

Study Arms (1)

89Zr-TLX250

EXPERIMENTAL

Patients will be injected with a single dose of 89Zr-TLX250.

Radiation: 89Zr-TLX250 PET/CT

Interventions

89Zr-TLX250 PET/CT RADIATION

Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.

89Zr-TLX250

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- For basket 3: GEP-NENs (2019 WHO classification), functioning or non-functioning, for the staging of patients with no, low or heterogeneous SSTR2 expression (who may be considered not eligible for PRRT with radiolabelled so- matostatin analogs).
• Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
• Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
• For cirrhotic patients: Child-Pugh ≤ B7.
• Patient affiliated to or beneficiary of the National Health Service.

You may not qualify if:

• Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
• Cardiac disease with New York Heart Association classification of III or IV.
• Life expectancy shorter than 4 months.
• Any major surgery within 4 weeks before enrollment.
• Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.
• Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years.
• Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential.
• Patient under guardianship or trusteeship.
• Patient under judicial protection.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Nantes

Nantes, France

RECRUITING

AP-HP - Site de Beaujon

Paris, France

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Central Study Contacts

Clément BAILLY

CONTACT

+33240084136; clement.bailly@chu-nantes.fr

Astrid GARREAU

CONTACT

+33253482840; astrid.garreau@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): August 4, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (2)