89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study

Prior treatment

• Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
• Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
• Exposure to murine or chimeric antibodies within the last 5 years.
• Previous administration of any radionuclide within 10 half-lives of the same.
• Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.

Other illness

• Active non-renal malignancy requiring therapy during the time frame of the study participation.
• Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the study subject, as judged by the investigator.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Known hypersensitivity to girentuximab or desferoxamine (DFO).

Lab values

• Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².

Other

• A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
• Renal mass known to be a metastasis of another primary tumour.
• Multiple unilateral or bilateral IRM.
• Women who are pregnant or breastfeeding.
• Vulnerable patients (e.g., being in detention).

• Written and voluntarily given informed consent.
• Mainland Chinese male or female, aged ≥ 18 years.
• Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
• Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
• Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
• Sufficient life expectancy to justify nephrectomy.
• Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.