Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

Inclusion criteria

• Voluntarily signed written informed consent
• Chinese male or female≥18 years old.
• Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
• Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
• Expected survival ≥ 6 months.
• Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.

Exclusion criteria

• Renal mass is known to be a metastasis of another primary tumor.
• Have other malignancies that require treatment.
• Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
• Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 [NCICTCAE v5.0]).
• Exposure to murine or chimeric antibodies within the last 5 years.
• Prior use of radionuclides with an interval of less than 10 halflives.
• Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX250.
• Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
• Uncontrolled psychiatric disorders.
• Women who are pregnant or breastfeeding.
• Known hypersensitivity to girentuximab or DFO (deferoxamine).
• Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
• Vulnerable population (e.g., being in detention).