First-in-patient trials – Clinical Study of Bladder Cancer.

Bladder cancer is the sixth most commonly occurring cancer in men, and the tenth most common cancer overall worldwide.

Telix Pharmaceuticals Limited announces that a first patient has been dosed in a Phase I study of TLX250-CDx in patients with urothelial carcinoma or bladder cancer at the Fiona Stanley Hospital in Perth, Western Australia.

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 localized and metastatic urothelial carcinoma or bladder cancer. Carbonic anhydrase IX (CA9) is a target that is overexpressed in many solid tumors, including urologic malignancies. ZiP-UP is an investigator-led study conducted by Professor Dickon Hayne at the Fiona Stanley Hospital in Perth, Australia with the goal of evaluating how CA9 imaging can be utilized 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 ten patients that require primary staging of localized urothelial carcinoma or bladder cancer.

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. Other collaborative studies are in development for ovarian, triple negative breast, colorectal, head and neck, lung, and pancreatic cancers.

Principal Investigator for the ZiP-UP study, Professor Dickon Hayne stated, “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.”

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.”

About Bladder Cancer and Urothelial Carcinoma

Bladder cancer is the sixth most commonly occurring cancer in men, and the tenth most common cancer overall worldwide.In 2020, 573,278 people worldwide were diagnosed with bladder cancer and 212,536 people died from their disease. Urothelial carcinoma (or UCC) accounts for ~90% of all bladder cancers. UCC also accounts for 10% to 15% of kidney cancers diagnosed in adults.

About TLX250-CDx

TLX250-CDx is being developed by Telix for the purpose of determining whether “indeterminate renal masses”, typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation5 for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.


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