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

Summary

Objectives

This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate
sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed
Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC)
in adult patients with indeterminate renal masses (IRM), scheduled for partial or total
nephrectomy.

Patients, will be recruited in 12-15 renal cancer care specialist centres, who have
access to state-of-the-art PET/CT imaging equipment.

The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted
5 +/-2 days post administration. The partial/total nephrectomy will then be performed at
institutional discretion any time following the PET/CT imaging visit, but no later than
90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared
and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a
central laboratory.

On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be
obtained. In patients, in which unexpected evidence for disseminated disease is observed,
PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at
the discretion of the investigator.

Image data analyses will be performed by a central image core lab. Qualitative visual
analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of
renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test
performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using
histological results from the central histological reference laboratory as standard of
truth.