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

Prior treatment

• 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.
• Any major surgery within 4 weeks before enrollment.

Other illness

• 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.
• 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.

Lab values

• 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.
• 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.

Other

• Uncontrolled brain or spinal cord metastasis.
• Life expectancy shorter than 4 months.
• Patient under guardianship or trusteeship.
• Patient under judicial protection.

• 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: Progressive GEP-NENs with low or heterogeneous expression of SSTR2 or progressive pancreatic NENs which previously received at least two systemic treatments (excluding SSA) or pancreatic NENs with germline or somatic VHL mutation or G3 GEP-NENs .
• 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.