First Patient Dosed in Telix’s Phase 3 LUTEON Trial of TLX250-Tx for Kidney Cancer

Telix Pharmaceuticals has dosed the first patient in its Phase 3 LUTEON trial evaluating TLX250-Tx, marking the first Phase 3 study of a CAIX-targeted radiopharmaceutical therapy for patients with relapsed or recurrent clear cell renal cell carcinoma (ccRCC).
The first patient was treated at GenesisCare Murdoch in Western Australia under the supervision of principal investigator Aviral Singh, MD. LUTEON is a randomized, prospective, open-label, multicenter study designed to evaluate the safety, tolerability, and efficacy of the investigational therapy in patients with recurrent or relapsed ccRCC.
"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," said Dr. Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch. "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."
TLX250-Tx is a first-in-class radiopharmaceutical antibody-drug conjugate (rADC) that combines a high-specificity monoclonal antibody with the therapeutic radionuclide lutetium-177. The therapy targets carbonic anhydrase IX (CAIX), a protein expressed in more than 95% of clear cell renal cell carcinomas while showing limited expression in normal tissues.
"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," said David N. Cade, MD, Telix Group Chief Medical Officer. "We aim to further evaluate the potential of TLX250-Tx, which 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."
The Phase 3 study is being conducted in Australia and is part of Telix's broader global development program for TLX250-Tx, which also includes the Phase 2a LUTEON ATLAS study in the United States and Europe. The trial uses Telix's investigational PET imaging agent, TLX250-Px (Zircaix), to identify patients with CAIX-positive tumors who are eligible for treatment.
Renal cell carcinoma accounts for approximately 90% of kidney cancer diagnoses, with clear cell renal cell carcinoma representing about 85% of RCC cases. Up to 30% of patients present with metastatic disease at diagnosis, highlighting the need for new treatment options.