TLX597-Tx / Telix - LARVOL DELTA

Dose optimisation and PSMA receptor intensification with 177Lu-PSMA-597 in metastatic castration-resistant prostate cancer (mCRPC): The randomised phase II OPTIMAL-PSMA trial. (ASCO-GU 2026) - P2 | "A phase 1 dose escalation study previously found 22Gbq dose of 177LuPSMA-617 over 15 days to be safe and tolerable, but randomised data compared to conventional dosing are lacking. 177Lu-SPECT and PSMA PET quantitation will be used to assess both treatment response and compare biologic effective dose delivered with a dose intensified versus SoC 177LuPSMA administration. Clinical trial information: ACTRN12625000971437."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

OPTIMAL-PSMA Phase 2 investigator-initiated trial (IIT) evaluating TLX597-Tx for mCRPC completed patient enrollment of 120 patients (Telix Press Release)

Enrollment closed • Castration-Resistant Prostate Cancer

A Phase 2, Open-Label, Randomized Controlled Trial Evaluating Safety and Efficacy of Dose-Intensified Versus Standard Dosing Regimens of [177Lu]Lu-PSMA-597 in mCRPC (OPTIMAL-PSMA). (PubMed, J Nucl Med) - "Eligible participants must have mCRPC with disease progression after androgen receptor pathway inhibitor therapy, have received or are not considered medically fit for docetaxel chemotherapy, and demonstrate PSMA-avid disease on PET/CT. OPTIMAL-PSMA will determine whether a dose-intensified regimen of [177Lu]Lu-PSMA-597 is safe and improves depth of response and survival outcomes compared with the standard dosing regimen. The results of this study may redefine the optimal treatment scheduling for PSMA-targeted radiopharmaceutical therapy for patients with mCRPC."

Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix Pharmaceuticals…announced that the first patients have been dosed with TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) in the OPTIMAL-e trial, led by Professor Louise Emmett for patients with metastatic hormone-sensitive prostate cancer (mHSPC) at St Vincent’s Hospital in Sydney, Australia (GlobeNewswire) - "OPTIMAL-e is a single-arm, open-label trial, evaluating adaptive-dosed TLX597-Tx in combination with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) in men with mHSPC."

Trial status • Hormone Sensitive Prostate Cancer

Therapeutics Business Unit:…TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) (PRNewswire) - "Interim data from OPTIMAL-PSMA, an investigator-led, randomized, dose intensification study of TLX597-Tx in mCRPC, will be presented at the International Prostate Cancer Symposium in April 2026."

P2 data • Castration-Resistant Prostate Cancer