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

Launched by NANTES UNIVERSITY HOSPITAL · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to use a special imaging technique called PET/CT to help identify certain types of tumors in patients. The study focuses on patients with specific types of cancer: Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (ICC), or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms (GEP-NENs). Researchers will use a labeled antibody called girentuximab, which targets a specific protein found in these tumors, to see if it can help better visualize the cancer during imaging tests.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers that can't be treated with surgery. They should also have had previous treatments that didn't work. Participants will need to agree to join the study and will be monitored closely throughout. It's important to note that certain health conditions and recent treatments may prevent some people from participating. This study aims to improve how we detect and understand these cancers, potentially leading to better treatment options in the future.

Gender

ALL

Eligibility 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.