•  First patient dosed in Phase 3 LUTEON^[1] trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).
•  LUTEON is the first Phase 3 study of a CAIX^[2]-targeted radiopharmaceutical therapy in ccRCC

 Telix Pharmaceuticals Limited announced that the first patient has been dosed with TLX250-Tx (lutetium-177 (¹⁷⁷Lu) girentuximab tetraxetan) in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC.

The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh.

Dr. Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch and Principal Investigator on the LUTEON trial, commented, "Dosing the first patient in the LUTEON study marks an important milestone in the development of potential new treatment options for patients with relapsed or recurrent clear cell renal cell carcinoma. Despite advances in care, outcomes remain poor for many patients, underscoring the need for innovative therapeutic approaches. This study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally, and we look forward to helping advance the clinical evidence for this promising therapeutic candidate."

Dr. David N. Cade, Telix Group Chief Medical Officer, added, "LUTEON represents the next stage in Telix's global clinical development of TLX250-Tx and reflects our commitment to developing precision radiopharmaceuticals for patients with difficult-to-treat cancers. We aim to further evaluate the potential of TLX250-Tx that is designed to utilize the high prevalence of CAIX expression in ccRCC to deliver targeted radiation directly to tumor sites, while limiting exposure to healthy tissue."