{"entity":{"id":"girentuximab-zr89","kind":"drug","name":"Zirconium-89 girentuximab","aka":["89Zr-DFO-girentuximab","Zircaix"],"tldr":"Zirconium-89 girentuximab is Telix's PET scan that tells whether a kidney mass is clear cell renal cell carcinoma without a biopsy; the phase 3 ZIRCON trial met its endpoints in 2023 and the product is under regulatory review.","summary":"Telix Pharmaceuticals' TLX250-CDx labels the anti-CAIX antibody girentuximab with zirconium-89. In the ZIRCON phase 3 trial of 300 patients with indeterminate renal masses, the scan identified clear cell renal cell carcinoma with high sensitivity and specificity against surgical histology. Telix filed with the FDA, which issued a refusal-to-file letter in 2024 over manufacturing information, and a resubmission followed. A further phase 3 trial is registered.","status":"phase-3","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of Zirconium-89 girentuximab","url":"https://clinicaltrials.gov/search?intr=TLX250-CDx"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["immuno-pet","pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct06750419"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"code":"TLX250-CDx","modality":"PET imaging antibody labelled with zirconium-89","mechanism":"Girentuximab binds carbonic anhydrase IX, expressed by nearly all clear cell renal cell carcinomas but not by normal kidney; the zirconium-89 label shows the tumour on PET days after injection.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/girentuximab-zr89/","neighbours":{"cancer":[{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"technology":[{"id":"immuno-pet","kind":"technology","name":"Immuno-PET","route":"/technologies/immuno-pet/"},{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"}],"trial":[{"id":"nct06750419","kind":"trial","name":"89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study","route":"/trials/nct06750419/"}]}}