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MELBOURNE, Australia, June 18, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited TLX Telix, the Company) today announces that the first patient has been dosed in a Phase II study of the Company’s carbonic anhydrase- (CAIX)-targeting PET/CT[1] imaging agent TLX250-CDx (89Zr-DFO-girentuximab), exploring this potential target across a broad range of cancer indications.
The STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) is a prospective, open label Phase II “basket” study to investigate CAIX expression in patients with a diverse range of solid tumours – including breast, cervix, colorectal, gastric, esophageal, head and neck, lung, ovarian, pancreatic and vulval cancers[2] – for potential diagnostic and therapeutic applications.
CAIX is a protein overexpressed on the surface of clear cell renal cell carcinoma (ccRCC), the cancer target in Telix’s highly successful Phase III ZIRCON study.[3] It is also expressed to varying degrees in many other advanced-stage solid tumours with poor prognosis. Tumours that express CAIX are typically hypoxic, more aggressive and feature a tumour micro-environment (TME) that can be resistant to therapy, particularly immunotherapies.
STARBURST is exploring these tumour types in the refractory setting to assess whether tumour sites can be targeted, both for imaging and potentially therapeutic purpose. The study builds on encouraging preliminary data from two investigator-initiated studies in triple-negative breast cancer and non-muscle-invasive bladder cancer, which demonstrate the potential of TLX250-CDx in these disease settings with unmet medical need. The half-life of 89Zr means that imaging these tumours with TLX250-CDx will enable predictive dosimetry for therapeutic radionuclides, effectively serving as a theranostic “scouting” study for future studies harnessing therapeutic radionuclides.
Principal Investigator for the STARBURST study, Dr Jackson Kiser, Medical Director Molecular Imaging at Carilion Clinic in
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