Telix is pioneering a new cancer modality
We are passionate about improving the quality of life for people with cancer and rare diseases. And we put our patients at the heart of everything we do.
With over 20 clinical trials underway worldwide across a range of diseases, Telix is at the forefront of theranostic drug development.
Telix clinical trials
Telix is pushing the frontiers of diagnostic and therapeutic nuclear medicine through a number of clinical trials, both company-sponsored and in collaboration with leading cancer centres around the globe.
Prostate cancer / PSMA
| Name / Study | Study Title | Sponsor | Asset | Disease | Intervention | Phase | Status | Location |
|---|---|---|---|---|---|---|---|---|
| University of Linz Prostate Cancer | Comparative study of 68Ga-PSMA-11 PET/CT and 18F-fluorocholine PET/CT in the detection of recurrence in prostate cancer patients after radical treatment | University of Linz | TLX591-CDx | Prostate Cancer | Imaging | III | Complete | Austria |
| Emory University Prostate Cancer Study ID: NCT03762759 | Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes | Emory University | TLX591-CDx | Prostate Cancer | Imaging | II | Recruiting | US |
| ENHANCING Study ID: ACTRN12619000720112 | Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer. | GenesisCare | TLX591-CDx | Prostate Cancer | Imaging | II | Recruiting | Australia |
| Memorial Sloan Kettering Prostate Cancer Study ID: NCT03204123 | PSMA PET Imaging of Recurrent Prostate Cancer | Memorial Sloan Kettering Cancer Center | TLX591-CDx | Prostate Cancer | Imaging | II | Active, not recruiting | US |
| NOBLE Registry NOBLE Registry | The NOBLE Registry is collecting prospective, real-world clinical data on the use of Telix’s SPECT-based investigational imaging product TLX599-CDx (99m Tc-iPSMA) | Telix and Oncidium Foundation | TLX599-CDx | Prostate Cancer | Imaging | NA | Recruiting | Global |
| ProstACT GLOBAL Study ID: NCT04876651 | 177Lu-DOTA-rosopatamab With Best Standard of Care (SoC) for the Second Line of Treatment for Metastatic Castrate-resistant Prostate Cancer, which Expresses PSMA | Telix | TLX591 | Prostate Cancer | Therapy | III | Sites being prepared | Global |
| ProstACT TARGET Study ID: NCT05146973 | External Beam Therapy with Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer. A collaborative study with GenesisCare | Telix | TLX591 | Prostate Cancer | Therapy | II | Recruiting | Australia |
| ProstACT SELECT Study ID: NCT04786847 | 177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study | Telix | TLX591 | Prostate Cancer | Therapy | I | Complete | Australia |
| CUPID Study ID: NCT04726033 | 64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (CUPID) | Telix | TLX592 | Prostate Cancer | Therapy (2nd Gen) | I | Recruiting | Australia |
| Emory Breast Cancer Study ID: NCT04750473 | Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer | Emory University | TLX591-CDx | Lobular Breast Cancer | Imaging | I | Recruiting | US |
| China Registration Study Study ID: NCT05847348 | 68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients | Telix | TLX591-CDx | Prostate Cancer | Imaging | III | Recruiting | China |
Kidney cancer / CAIX
| Name / Study | Study Title | Sponsor | Asset | Disease | Intervention | Phase | Status | Location |
|---|---|---|---|---|---|---|---|---|
| ZIRCON Study ID: NCT03849118 | 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (89ZR-TLX250) | Telix | TLX250-CDx | Kidney Cancer | Imaging | III | Complete | Global |
| ZIRDAC-JP Study ID: NCT04496089 | Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr- TLX250 in Subjects with RCC (ZIRDAC-JP) | Telix | TLX250-CDx | Kidney Cancer | Imaging | I/II | Complete | Japan |
| STARLITE-1 Study ID: NCT05663710 | Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC | MD Anderson Cancer Center | TLX250 | Kidney Cancer | Therapy | II | Recruiting | US |
| STARLITE-2 Study ID: NCT05239533 | Study of Nivolumab in Combination With 177Lu-girentuximab for Kidney Cancer | Memorial Sloan Kettering Cancer Center | TLX250 | Kidney Cancer | Therapy | II | Recruiting | US |
| OPALESCENCE Study ID: NCT04758780 | Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients | Institut Cancerologie de l’Ouest | TLX250-CDx | Triple Negative Breast Cancer | Imaging | II | Complete | France |
| PERTINENCE Study ID: NCT04897763 | Assessment of Safety, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr- labeled girentuximab (89Zr-Girentuximab) in Patients with Non-Muscle-Invasive Bladder Cancer | Institut Cancerologie de l’Ouest | TLX250-CDx | Non-Muscle-Invasive Bladder Cancer | Imaging | I | Complete | France |
| ZiP-UP Study ID: NCT05046665 | A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients | South Metropolitan Health Service | TLX250-CDx | Bladder or Urothelial Cancer | Imaging | I | Recruiting | Australia |
| ZIRDOSE-CP Study ID: NCT05861778 | Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma | Telix | TLX250-CDx | Kidney Cancer | Imaging | I | Recruiting | China |
| STARBURST Study ID: NCT05563272 | Exploration of CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumors. | Telix | TLX250-CDx | CAIX Expressing Solid Tumors | Imaging | II | Recruiting | US |
| STARSTRUCK Study ID: NCT05868174 | Evaluation of different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors. | Telix | TLX250 | CAIX Expressing Solid Tumors | Therapy | Ib | Recruiting | Australia |
Glioblastoma / LAT-1
| Name / Study | Study Title | Sponsor | Asset | Disease | Intervention | Phase | Status | Location |
|---|---|---|---|---|---|---|---|---|
| IPAX-2 Study ID: NCT05450744 | 131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma | Telix | TLX101 | Glioblastoma | Therapy | I/II | Recruiting | Australia, New Zealand |
| IPAX-Linz | TBC | Kepler University Hospital | TLX101 | Glioblastoma | Therapy | II | Recruiting | Austria |
Bone marrow conditioning
| Name / Study | Study Title | Sponsor | Asset | Disease | Intervention | Phase | Status | Location |
|---|---|---|---|---|---|---|---|---|
| TRALA Study ID: 2015-002231-18 | A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis | University Southampton Hospital NHS Foundation Trust | TLX66 | AL-Amyloidosis | Therapy | I/IIa | Complete | UK |
| GOSH Study ID: NCT04856215 | Open Label, Phase II Study of 90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia | Great Ormond Street Hospital | TLX66 | Pediatric Leukemia | Therapy | II | Active | UK |
Compassionate use
Telix is often contacted to provide access to our products under compassionate use. We respect the treatment journey of the patient and the independence of healthcare professionals in making their treatment decisions. Telix tries to accommodate such requests whenever it is clinically, ethically and practically feasible to do so.
You can find Telix’s compassionate use policy here: