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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provided written informed consent. 2. Patients aged ≥ 18 years. 3. Histologically confirmed, unresectable locally advanced or metastatic solid tumors of:

- HCC or ICC: expressing CAIX (less than 2 years), not eligible for local or loco- regional treatment, after failure of first line systemic therapy.

In addition, for ICC, after targeted therapy in case of IDH1 mutation or FGFR fusion.

- Progressive GEP-NENs (2019 WHO classification), functioning or non-function- ing, without or with low SSTR2 expression, after at least one line of standard therapy.

4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI. 5. Patients should not have received further antitumor therapy once disease progression is documented. 6. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2. 7. For cirrhotic patients: Child-Pugh A. 8. 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 4 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 or refusing effective contraception method. 12. Patient under guardianship or trusteeship. 13. Patient under judicial protection.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06735560
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nantes University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors

Arms & Interventions

Arms

Experimental: 89Zr-TLX250

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

Interventions

Radiation: - 89Zr-TLX250 PET/CT

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

Contact a Trial Team

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