Study launches of novel imaging radiopharmaceutical in NMIBC

The first patient has been dosed in the phase 1 PERTINENCE study exploring the novel PET imaging radiopharmaceutical TLX250-CDx (⁸⁹Zr-girentuximab) in patients with non–muscle-invasive bladder cancer (NMIBC).¹

The patient was dosed at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain, France. Caroline Rousseau, MD, PhD, of ICO is the lead researcher on the study.

TLX250-CDx targets the receptor carbonic anhydrase IX (CA9), which is overexpressed inurologic cancers, as well as many other solid tumors, according to Telix andATONCO, the companies developing TLX250-CDx.

Overall, the proof-of-concept, open-label PERTINENCE study is evaluating the biodistribution, dosing, and safety of TLX250-CDx in patients with NMIBC. The target enrollment goal for the small study is 6 patients over 12 months. If the results of the study are positive, the researchers intend to explore TLX250-CDx as a foundation for therapy with astatine-211 (²¹¹At), an alpha-emitting radioisotope.

“CA9 is a very interesting target that is highly expressed in many hypoxic solid tumors. This study builds on the clinical work we are already doing with CA9 in the OPALESCENCE study and will help us generate a better understanding of the imaging properties of TLX250-CDx in NMIBC as a precursor to studying the role of girentuximab as a therapy with an alpha emitting radioisotope,” Rousseau stated in a news release.¹

TLX250-CDx in kidney cancer

TLX250-CDx is also being explored in kidney cancer. The ongoing phase 3 ZIRCON trial (NCT03849118) is evaluating the capacity of TLX250-CDx to identify clear cell renal cell carcinoma (RCC) in patients with indeterminate renal masses.²

The prospective, international, open-label, single-group assignment study is enrolling patients who are scheduled for partial or total nephrectomy.³ The study is being conducted at 36 locations in Europe, Australia, Turkey, Canada, and the United States. The targeted enrollment is 252 patients and the estimated primary completion date is December 31, 2021. The primary outcome measures are sensitivity and specificity.

The FDA granted a Breakthrough Therapy Designation to TLX250-CDx in July 2020 for the diagnosis and staging of indeterminate renal masses.⁴ The designation is intended to expedite the development and regulatory review of the imaging radiopharmaceutical in this setting.

References

1. First Patient Dosed in Study of Targeted Alpha Therapy Candidate for Bladder Cancer. Published online December 21, 2021. Accessed January 24, 2022. https://bit.ly/3Ar3Lp0

2. First U.S. Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product. Published online January 25, 2021. Accessed January 25, 2021. https://bit.ly/39gwHnK

3. NIH US National Library of Medicine ClinicalTrials.gov. 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (89ZR-TLX250). Last updated October 19, 2020. Accessed January 25, 2021. https://clinicaltrials.gov/ct2/show/NCT03849118

4. Telix Granted FDA Breakthrough Therapy Designation for Renal Cancer Imaging Product. Published online July 1, 2020. Accessed January 25, 2021. https://bit.ly/39hkIpT