TELIX CLINICAL TRIALS
Telix is pushing the frontiers of diagnostic and therapeutic nuclear medicine through a number of significant clinical trials, both company-sponsored and in collaboration with leading cancer centres around the globe.
89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (89Zr-TLX250)
A confirmatory, prospective, open-label, multi-centre phase III study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250)to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)
Phase III diagnostic imaging trial focussing on the sensitivity and specificity of 89Zr-TLX250 in the detection of ccRCC in patients diagnosed with an indeterminate renal mass scheduled for surgical resection.
Trial Reference: NCT03849118
89Zr-TLX250 PET/CT imaging study of ccRCC as Phase I / Phase II
Phase I / Phase II (ZIRDAC-JP) Phase I/II study to be conducted in Japan to look at safety and tolerability, as well as dosimetry of 89Zr-TLX250 in the Japanese population.
Phase II study is designed to evaluate at the diagnostic performance of 89Zr-TLX250 in detecting ccRCC by PET/CT imaging in patients with an indeterminate renal mass
Trial Reference: RECRUITMENT COMPLETED
Phase I bridging study using 89Zr-TLX250 to image ccRCC. The trial was designed to evaluate dosimetry and image quality between 5mg versus 10mg mass doses of TLX250 radiolabelled with 37MBq of 89Zr EudraCT 2017-004769-2
Trial Reference: EudraCT 2017-004769-2
Phase Ib/II combination study with 177Lu-TLX250 with duo of pembrolizumab+axitinib in front line metastatic ccRCC. Study endpoint in Phase 1b will be the maximal tolerated dose of 177Lu-TLX250 in combination with pembrolizumab+axitinib combination. Study endpoint in Phase II will be complete response rate with the combination therapy
Trial Reference: Pending
Telix is a collaborator with MD Anderson Cancer Center
Phase II trial evaluating the combination therapy of 177Lu-TLX250 with ipilimumab+nivolumab in metastatic ccRCC patients who have progressed on initial checkpoint inhibitor or TKI therapy. Endpoints include safety and tolerability and objective response rate with this combination
Trial Reference: Pending
Telix is a collaborator with Memorial Sloan Kettering Cancer Center
40 patient single centre investigator-led trial to evaluate the if androgen blockade with enzalutamide increases the diagnostic sensitivity of 68Ga-PSMA-11 imaging in patients with castrate resistant metastatic prostate cancer versus castrate sensitive prostate cancer
Trial Reference: ACTRN12619000720112
Telix is a collaborator with Genesis Care
FLUCICLOVINE 18F or 68Ga-PSMA PET/CT
Fluciclovine 18F or 68Ga-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Phase II trial to compare the performance of a PET/CT using 18F-fluciclovine and PET/CT using 68Ga-PSMA in the planning of radiation therapy and enhancing the outcomes of patients with prostate cancer
PSMA PET IMAGING OF RECURRENT PROSTATE CANCER
Recruitment of prostate cancer patients that show high-risk features with evidence of biochemical recurrence with PSA level between 0.02 – 2.0ng/ml after surgery. These patients will undergo a PET/CT scan with PSMA-11
Trial Reference: NCT03204123
Telix is a collaborator with Memorial Sloan Kettering Cancer Centre
Phase III therapeutic trial in metastatic prostate cancer using 177Lu-rosapatumab (TLX591) plus second-line standard care vs standard care alone. Endpoints include PSA response, PFS and OS
Trial Reference: NCT04876651
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)
Phase III study comparing the efficacy of 177Lu-PSMA 617 plus best standard of care versus best standard of care alone in the setting of progressive PSMA positive metastatic prostate
Trial Reference: NCT03511664
Telix is a global collaborator/imaging provider to Endocyte/Novartis.
Active, not recruiting
Phase I/II open label trial to evaluate preliminary safety and efficacy of 131I-TLX101 in combination with standard of care external beam radiation therapy in patients with recurrent glioblastoma
Trial Reference: NCT03849105
With the exception of Telix’s 68Ga PSMA-11 imaging agent in Australia and the United States, none of Telix’s products have received a marketing authorisation in any jurisdiction. Any use of Telix products is on an investigational basis only.