Telix doses first patient in Phase 3 renal cancer trial

MELBOURNE, Australia and INDIANAPOLIS, July 21, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today 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."

TLX250-Tx

TLX250-Tx is a first-in-class CAIX-targeting rADC^[3] therapy candidate composed of a high-specificity monoclonal antibody chelated to the therapeutic radionuclide lutetium-177. CAIX is an attractive therapeutic target because it is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue^[4],[5].

LUTEON is being run under a Phase 3 protocol in Australia and forms part of Telix's global development program for TLX250-Tx, which includes the separate Phase 2a LUTEON ATLAS study in the United States and Europe.

The LUTEON study utilizes Telix's investigational PET^[6] imaging agent, TLX250-Px (Zircaix®^[7], zirconium-89 (⁸⁹Zr) girentuximab senvedoxam), to identify eligible patients with CAIX-positive tumors.

Renal Cell Carcinoma

Renal Cell Carcinoma, RCC, is the most common form of kidney cancer, accounting for approximately 9 out of 10 diagnoses^[8]. Within this category, ccRCC is the most common and often the most aggressive subtype, representing about 85% of all RCC cases^[9] with up to 30% of patients presented with metastatic disease at diagnosis, which has a 20% 5-year survival rate^[10],[11].

[1] ClinicalTrials.gov ID: NCT07197580.

[2] Carbonic Anhydrase IX.

[3] Radio antibody-drug conjugate.

[4] Luong-Player A, et al. Am J Clin Pathol. 2014.

[5] Kleinendorst SC, et al. Theranostics. 2024.

[6] Positron emission tomography.

[7] Brand name subject to final regulatory approval.

[8] Bukavina, L, et al. Eur Urol. 2022.

[9] Alchahin AM, et al. Nat Commun. 2022.

[10] National Cancer Institute. Cancer stat facts: kidney and renal pelvis cancer. Updated 2025. Accessed May 1, 2026. https://seer.cancer.gov/statfacts/html/kidrp.html.

[11] Vento JA, et al. Cancers (Basel). 2022.