177Lu-DOTA-girentuximab (TLX250)

[89Zr]Zr-girentuximab PET/CT is a sensitive imaging method and offers promise for novel theranostics for mTNBC patients.

P3, N=40, Not yet recruiting, Telix Pharmaceuticals (Innovations) Pty Limited

P1, N=12, Recruiting, NYU Langone Health | Not yet recruiting --> Recruiting

P1, N=12, Not yet recruiting, NYU Langone Health

Preclinical and clinical data demonstrate the promising therapeutic role of 211At-targeted alpha agents in NMIBC, and the [211At]At-anti-CA-IX antibody (ATO-101™) could fulfill this role. A phase I FIH clinical trial is in preparation, and results are expected within the next years.

177Lu-DOTA-girentuximab (targeting carbonic anhydrase IX) or 177Lu-DOTA-rosopatamab (targeting prostate-specific membrane antigen) was used to deliver β-radiation to tumors via a single intravenous dose (3 or 6 MBq) in mice bearing SK-RC-52 RCC or LNCaP prostate cancer xenografts, respectively. Our findings suggest a synergistic effect between peposertib and 177Lu-based radioimmunotherapy, wherein peposertib enhanced the efficacy of radioimmunotherapy. This synergy indicates the potential to reduce the necessary dose of radioimmunotherapy for effective cancer treatment.

P1, N=36, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Phase classification: P1b --> P1

P1b, N=36, Recruiting, Telix International Pty Ltd | Not yet recruiting --> Recruiting

P1b, N=36, Not yet recruiting, Telix International Pty Ltd

Coprimary objectives were to evaluate both the sensitivity and specificity of TLX250-CDx PET/CT imaging in detecting ccRCC in patients with IDRM, using histology as standard of truth. 89 Zr-DFO-girentuximab PET/CT is well tolerated and can accurately and noninvasively identify and characterize IDRMs, showing promising utility for guiding surgical and treatment decisions.

89Zr-DFO-girentuximab (hereafter referred to as TLX250-CDx) is a diagnostic radiopharmaceutical for PET imaging that targets CAIX and has demonstrated clinical success in ccRCC imaging. Statistics will be descriptive with no formal hypothesis. The study is ongoing.