ZIRCON Phase III Renal Cancer Study to be Presented at ASCO GU along with Theranostic Pipeline Advances


Telix Pharmaceuticals Limited reports that an oral presentation of the recently finished pivotal Phase III ZIRCON study of TLX250-CDx (Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) will take place at the upcoming 2023 ASCO GU Symposium, which will take place in San Francisco, California, from February 16–18, 2023.

The Company will reveal all study primary and secondary end-points as well as specific grading criteria linked to lesion size and identification at ASCO GU, the foremost specialised event for GU cancer care worldwide.

The programme will also include six talks on the theranostic candidates from Telix that target the proteins carbonic anhydrase IX (CAIX) and prostate specific membrane antigen (PSMA). The STARLITE Phase II studies, which are evaluating the efficacy of TLX250 (177Lu-DOTA-girentuximab) targeted radiation in combination with immunotherapy for ccRCC, and the advancements in positron emission tomography (PET) imaging of prostate cancer with Ga PSMA-11 will also be covered in presentations.

“Telix’s vision is to drive innovation in urologic oncology across the patient continuum, harnessing the power of targeted radiation from imaging, to surgery and therapy. We are therefore excited to be so well represented at ASCO-GU, the leading specialised event for GU cancer care worldwide. A highlight will be the first presentation of finalised, detailed clinical data from the Phase III ZIRCON study of TLX250-CDx, which reported highly positive topline data in November. The congress program also includes updates on Telix-sponsored and investigator-initiated diagnostic and therapeutic studies and research collaborations across prostate and kidney cancer, and other tumour types. We look forward to seeing you at our booth.”

Dr Colin Hayward, Chief Medical Officer, Telix.

Following the presentation of results, an investor conference call and webcast will be held; joining information will be provided prior to the event. ASCO GU presentation materials will be posted to the ASX.

ASCO GU presentation details are as follows:

  • Session: Oral Abstract Session C: Renal and Rare Tumors
  • Title: Results from phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma (ZIRCON)
  • Date and Time: 18-Feb-2023, 2:00 PM-3:30 PM
  • Presenter: Brian Shuch (UCLA)
  • Abstract ID: LBA602

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Date and Time: 17-Feb-2023, 12:30 PM-2:00 PM & 5:15 PM-6:15 PM

  • Title: “68Ga-PSMA-11 patients with newly diagnosed and recurrent prostate cancer (Firefly Study) – Preliminary Results.”
  • Presenter: Hawkins, Charlotte (Telix); senior author: Oliver Sartor (Tulane Cancer Center)
  • Abstract ID: 54
  • ClinicalTrials.gov Identifier: NCT04854369


  • Title: “Ga-68 PSMA-11 (Illuccix) impacting prostate cancer management in a real-world setting: a pilot experience using the total-body PET/CT scanner (uExplorer).”
  • Presenter: Hashad Kulkarni (BAMF Health)
  • Abstract ID: 62


  • Title: “Special access use of 68Ga-PSMA-11 in Canada: real world experience.”
  • Presenter: Philip Cohen (Initio Medical)
  • Abstract ID: 102

Trials in Progress Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers

Date and Time: 18-Feb-23, 07:00 AM-08:00 AM & 12:30 PM-2:00 PM

  • Title: “89Zr-DFO-girentuximab for PET imaging of solid tumors likely to express high levels of carbonic anhydrase IX” (STARBURST study)”
  • Presenter: Andrei Iagaru (Stanford University)
  • Abstract ID: TPS738
  • ClinicalTrials.gov Identifier: NCT05563272


  • Title: “Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC” (STARLITE 1 study)
  • Presenter: Elshad Hasanov (MD Anderson Cancer Center)
  • Abstract ID: TPS749


  • Title: “Phase 2 Study of Nivolumab plus 177Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-girentuximab) in Patients (pts) with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)” (STARLITE 2 study)
  • Presenter: Darren Feldman (Memorial Sloan Kettering Cancer Center)
  • Abstract ID: TPS752
  • ClinicalTrials.gov Identifier: NCT05239533
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