GlobeNewswire·Jul 20, 2026, 5:00 PM ET

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

TLX

Telix Pharmaceuticals announced the dosing of the first patient in the Phase 3 LUTEON trial for TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).
LUTEON is the first Phase 3 study of a CAIX-targeted radiopharmaceutical therapy for ccRCC & is a randomized, prospective, open-label, multi-center study.
The initial patient was dosed at GenesisCare Murdoch in Western Australia under the supervision of Principal Investigator Dr. Aviral Singh.
TLX250-Tx is a first-in-class CAIX-targeting radio antibody-drug conjugate utilizing lutetium-177 to deliver targeted radiation to tumors while limiting exposure to healthy tissue.
CAIX is expressed in more than 95% of ccRCC cases & demonstrates limited expression in normal tissues including kidney tissue.
The LUTEON study is conducted in Australia & utilizes Telix's investigational PET imaging agent TLX250-Px (Zircaix) to identify patients with CAIX-positive tumors.
This Australian protocol is part of Telix's global development program which also includes the separate Phase 2a LUTEON ATLAS study in the United States & Europe.
ccRCC represents approximately 85% of renal cell carcinoma cases & up to 30% of patients present with metastatic disease at diagnosis with a 20% 5-year survival rate.
TLX250-Tx & TLX250-Px have not received marketing authorization in any jurisdiction as of July 2026.
Telix Pharmaceuticals is a commercial-stage radiopharmaceutical company headquartered in Melbourne with a pipeline including assets for prostate cancer, glioblastoma, & kidney cancer.