Telix doses first patient in phase 3 LUTEON trial of TLX250-Tx for Renal cancer

CAR-T Digest - August 2020

Weekly Digest - July 2026

21 July 2026: Telix doses first patient in phase 3 LUTEON trial of TLX250-Tx for Renal cancer

Telix Pharmaceuticals announced the first patient dosing in the pivotal phase 3 LUTEON trial evaluating TLX250-Tx, marking the first CAIX-targeted radiopharmaceutical therapy to enter phase 3 development for patients with relapsed or recurrent clear cell renal cell carcinoma
The randomized, open-label, multicenter LUTEON trial will evaluate TLX250-Tx versus investigator’s choice of monotherapy in patients with advanced relapsed or recurrent ccRCC. The study will first determine the recommended phase 3 dose before proceeding to compare efficacy and safety against standard-of-care treatment
The program addresses a significant unmet need in advanced ccRCC, where patients who relapse following current therapies continue to have poor outcomes despite recent treatment advances. The study also represents an important milestone for targeted radiopharmaceutical therapy in kidney cancer
TLX250-Tx is a CAIX-targeted radiolabeled antibody conjugate that combines the monoclonal antibody girentuximab with the therapeutic radionuclide lutetium-177 to selectively deliver targeted radiation to CAIX-expressing tumor cells. The LUTEON trial utilizes Telix’s companion imaging agent TLX250-Px to identify eligible patients with CAIX-positive tumors
Strategically, first patient dosing in the LUTEON trial advances Telix’s radiopharmaceutical oncology pipeline, reinforces its leadership in CAIX-targeted kidney cancer therapies, and highlights the growing momentum of radiolabeled antibody conjugates as a differentiated therapeutic modality alongside conventional antibody-drug conjugates in solid tumors