A full listing of Telix clinical trials, which also includes active and completed studies can be found at ClinicalTrials.gov.
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PHASE III ProstACT GLOBAL STUDY
A multinational, multicenter, prospective, randomized, controlled, open label Phase III study designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu rosopatamab tetraxetan administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase III will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).
PHASE III CHINA REGISTRATION STUDY FOR ILLUCCIX
A Phase III study evaluating 68Ga-PSMA-11 efficacy in detecting BCR prostate cancer in Chinese patients, intended to bridge to U.S. FDA approval of Illuccix
PHASE III ZIRCON CHINA REGISTRATION STUDY
Registration study in Chinese patients intended to bridge to Telix's successful global Phase III ZIRCON trial of TLX250-CDx (89Zr-girentuximab), for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET).
TLX250-CDX EARLY ACCESS (U.S. AND EU)
Expanded Access Program (U.S.) and Named Patient Programs (EU) to enable the use of TLX250-CDx with PET/CT imaging to non-invasively detect carbonic anhydrase IX (CAIX)-expressing ccRCC in patients with renal masses as determined by conventional imaging.
PHASE II STARLITE-1 STUDY
A 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.
PHASE II STARLITE-2 STUDY
A 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.
PHASE II STARBURST STUDY
A prospective, open-label, phase II study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumours.
PHASE I STARSTRUCK STUDY
An open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumours.
PHASE I IPAX-2 STUDY
An open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.
TLX300-CDx in Soft Tissue Sarcoma (STS)
