Zircaix (TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan)) - (LUTEON)

July 21, 2026: Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced dosing of the first patient in LUTEON (ClinicalTrials.gov NCT07197580), a randomized, prospective, open-label, multi-center Phase 3 trial evaluating TLX250-Tx (lutetium-177 girentuximab tetraxetan) in patients with relapsed or recurrent clear cell renal cell carcinoma (ccRCC). The company states LUTEON is the first Phase 3 study of a CAIX-targeted radiopharmaceutical therapy in ccRCC. The first patient was dosed at GenesisCare Murdoch (Western Australia).

TLX250-Tx is described as a first-in-class CAIX-targeting radio antibody-drug conjugate composed of a monoclonal antibody linked to lutetium-177; CAIX is reported to be expressed in >95% of ccRCC. Patient selection in LUTEON uses Telix’s investigational PET imaging agent TLX250-Px (Zircaix®, zirconium-89 girentuximab senvedoxam) to identify CAIX-positive tumors.

Telix also noted its broader TLX250-Tx development program includes a separate Phase 2a LUTEON ATLAS study in the U.S. and Europe, and that TLX250-Tx and TLX250-Px are not yet authorized in any jurisdiction.