Phase II STARBURST Study of TLX250-CDx Begins with First Patient Dosed, Investigating Indication Expansion
Monday, June 19, 2023
Telix Pharmaceuticals Limited (ASX: TLX) has announced the commencement of a Phase II study for its PET/CT imaging agent TLX250-CDx (89Zr-DFO-girentuximab), which targets carbonic anhydrase (CAIX). The study, named STARBURST, is an open-label Phase II "basket" study that aims to explore CAIX expression in various solid tumor types, including breast, cervix, colorectal, gastric, esophageal, head and neck, lung, ovarian, pancreatic, and vulval cancers. The objective is to investigate the potential diagnostic and therapeutic applications of TLX250-CDx in these tumor types.
CAIX is a protein that is overexpressed on the surface of clear cell renal cell carcinoma (ccRCC), which was the target of Telix's successful Phase III ZIRCON study. It is also expressed to varying degrees in many other advanced-stage solid tumors with poor prognosis. Tumors that express CAIX are often hypoxic, more aggressive, and have a tumor microenvironment that can be resistant to therapy, including immunotherapies.
The STARBURST study aims to assess the potential of targeting CAIX in these refractory tumor types for both imaging and potentially therapeutic purposes. The study is based on promising preliminary data from two investigator-initiated studies in triple-negative breast cancer and non-muscle-invasive bladder cancer, which demonstrated the potential of TLX250-CDx in these disease settings with unmet medical needs. TLX250-CDx, with its 89Zr half-life, allows for imaging of these tumors and enables predictive dosimetry for therapeutic radionuclides, making it a valuable tool for future studies involving therapeutic radionuclides.
Dr. Jackson Kiser, the Principal Investigator for the STARBURST study and Medical Director of Molecular Imaging at Carilion Clinic in Roanoke, Virginia, expressed interest in exploring the potential utility of TLX250-CDx in tumor types known to express CAIX beyond ccRCC, which has already been validated in Telix's Phase III ZIRCON study.
Dr. Colin Hayward, Telix Chief Medical Officer, emphasized the strategic importance of initiating the STARBURST study, stating that it will provide valuable clinical insights and help assess the biomarker potential of CAIX as Telix continues to explore the therapeutic potential of targeting CAIX in indications beyond renal cancer. Telix expressed gratitude to Dr. Kiser and his clinical team at Carilion Clinic, as well as the patients participating in the study for their contribution.
