PHASE III ZIRCON CHINA REGISTRATION STUDY

Detection of renal masses is increasing due to widespread use of cross-sectional imaging but current imaging is unable to reliably distinguish benign or malignant lesions from ccRCC.

To evaluate sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in Chinese patients with indeterminate renal masses, using histology as standard of truth.

Secondary Outcome Measures:

1. To determine positive predictive value (PPV), negative predictive value (NPV), and accuracy of TLX250-CDx PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses, and in patients with indeterminate renal masses of ≤ 4 cm (cT1a).
2. To identify a standardised uptake value (SUV) cut-off for TLX250-CDx, suitable to discriminate ccRCC from non-ccRCC.
3. To establish safety and tolerability of TLX250-CDx in Chinese patients with IRM.
4. To assess if TLX250-CDx PET/CT has an impact on clinical decision making in patients with IRM vs conventional diagnostics and whether 89Zr-DFO-girentuximab PET/CT can prevent unnecessary biopsies or surgery.

1. Written and voluntarily given Informed Consent.
2. Mainland Chinese, male or female ≥18 years of age.
3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1), on CT or MRI with and without contrast agent, suspicious for ccRCC.
4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned TLX250-CDx administration.
5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product).
6. Sufficient life expectancy to justify nephrectomy.
7. Consent to practise highly effective contraception until a minimum of 42 days after IV TLX250-CDx administration.

1. A biopsy procedure only (rather than partial or total nephrectomy) planned for histological species delineation of IRM.
2. Renal mass known to be a metastasis of another primary tumour.
3. Active non-renal malignancy requiring therapy during the time frame of the study participation.
4. Multiple unilateral or bilateral IRM.
5. Chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the planned administration of TLX250-CDx or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
6. Planned antineoplastic therapies (for the period between administration of TLX250-CDx and imaging).
7. Exposure to murine or chimeric antibodies within the last 5 years.
8. Previous administration of any radionuclide within 10 half-lives of the same.
9. 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 subject, as judged by the investigator.
10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
11. 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 TLX250-CDx.
12. Women who are pregnant or breastfeeding.
13. Known hypersensitivity to girentuximab or desferoxamine (DFO).
14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
15. Vulnerable participants (e.g., being in detention).