First patient dosed in study of TLX250-CDx exploring indication expansion

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Telix (ASX:TLX) has announced that the first patient has been dosed in a global Phase 2 study of its imaging agent TLX250-CDx (89Zr-DFO-girentuximab).

The STARBURST study is a prospective, open-label 'basket' study to investigate carbonic anhydrase (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.

CAIX is a protein overexpressed on the surface of clear cell renal cell carcinoma. 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 microenvironment 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 purposes.

Telix chief medical officer Dr Colin Hayward said, “Building on the success of ZIRCON and positive preliminary results in investigator-initiated studies of TLX250-CDx in bladder and breast cancer, dosing a first patient in the STARBURST study is a strategically important milestone for Telix. This study will add value and clinical insight to the platform and enable Telix to assess the potential of CAIX as a biomarker as we continue to scout the theranostic potential of targeting CAIX beyond renal cancer. We would like to thank Dr Kiser and his clinical team at Carilion Clinic, as well as the patients who will contribute to the study.”