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

Nantes University Hospital (NUH)

Status: Enrolling

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

Treatments: Radiation: 89Zr-TLX250 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06735560

RC23_0453

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provided written informed consent.

2. Patients aged ≥ 18 years.

3. - 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).

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

5. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.

6. For cirrhotic patients: Child-Pugh ≤ B7.

7. Patient affiliated to or beneficiary of the National Health Service.

Exclusion criteria

1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to inclusion.
3. Radionucleide targeted therapy prior to inclusion within 6 months prior to inclusion.
4. Radioembolization within 3 months prior to inclusion.
5. Uncontrolled brain or spinal cord metastasis. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable brain disease 3 months prior to inclusion in the study.
6. Cardiac disease with New York Heart Association classification of III or IV.
7. Life expectancy shorter than 4 months.
8. Any major surgery within 4 weeks before enrollment.
9. 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.
10. 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.
11. 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.
12. Patient under guardianship or trusteeship.
13. Patient under judicial protection.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

89Zr-TLX250

Experimental group

Description:

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

Treatment:

Radiation: 89Zr-TLX250 PET/CT