TRIALS

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.

ZIRCON

Recruiting

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

ZIRDAC-JP

Pending

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: Pending

ZIRDOSE

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

IPAX-1

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

ENHANCING

Recruiting

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: CT-2019-CTN-00818-1 v2
Telix is a collaborator with Genesis Care

STARLITE-1

Pending

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 Memorial Sloan Kettering Cancer Center

STARLITE-2

Pending

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 MD Anderson Cancer Center

FLUCICLOVINE 18F or 68Ga-PSMA PET/CT

RECRUITING

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

Trial Reference: NCT03762759
Telix is a collaborator with Emory University

PSMA PET IMAGING OF RECURRENT PROSTATE CANCER

RECRUITING

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

PROSTACT

PENDING

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: Pending (protocol in review)

VISION

RECRUITING

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


None of Telix’s product pipeline has received marketing authorization in any jurisdiction. Any use of Telix products is on an investigational basis or for use in approved clinical trials.