Telix Pharmaceuticals (ASX:TLX) says a first patient has been dosed in a phase one study of TLX250-CDx (89Zr-DFO-girentuximab) in patients with urothelial carcinoma or bladder cancer at Fiona Stanley Hospital in Perth.
The company said the objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx PET/CT1 in the detection of localised and metastatic urothelial carcinoma or bladder cancer.
Carbonic anhydrase IX (CA9) is a target that is overexpressed in many solid tumours, including urologic malignancies.
ZiP-UP is an investigator-led study conducted by Professor Dickon Hayne at the Fiona Stanley Hospital in Perth with the goal of evaluating how CA9 imaging can be utilised for cancer diagnosis and staging and to develop a deeper understanding of the utility of CA9 as a therapeutic target in this patient population.
The trial will recruit 20 patients over 12 months - ten patients with known metastatic urothelial carcinoma or bladder cancer and patients that require primary staging of localised urothelial carcinoma or bladder cancer.
The company said ZiP-UP is the first in a series of studies that will harness TLX250-CDx to evaluate CA9 expression in cancers other than renal cancer, currently the focus of the ZIRCON (imaging) and STARLITE (therapy) studies.
It said other collaborative studies are in development for ovarian, triple-negative breast, colorectal, head and neck, lung, and pancreatic cancers.
Professor Hayne said, “In a cancer where outcomes are worsening throughout Australia, better staging and therapy planning are absolutely essential. We are therefore pleased to have dosed a first patient in this important diagnostic study, which has potential to extend into therapy via the ‘theranostic’ companion investigational asset, TLX250 (177Lu-DOTA-girentuximab).”
Telix CEO, Dr Christian Behrenbruch, added, “We are pleased that a first patient has been dosed in this study exploring the clinical utility of TLX250-CDx to image other cancers, beyond renal cancer, and in indications where conventional imaging has limitations. This candidate has been granted Breakthrough Therapy designation by the US FDA for renal cancer imaging and therefore it is meaningful to test the potential of CA9 targeting in other cancers with the goal of rapid indication expansion beyond the initial kidney cancer application. We wish to express our gratitude to Professor Dickon Hayne and his clinical team, as well as the patients that will contribute to the study.”