Telix Doses First Patient in Pioneering ZOLAR Trial for Advanced Soft Tissue Sarcoma

MELBOURNE, Australia, April 2, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR[1] trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia.

ZOLAR is a first-in-human, proof-of-concept and biodistribution trial that uses positron emission tomography (PET) to evaluate olaratumab, a monoclonal antibody, as a therapeutic radiopharmaceutical targeting platform. Olaratumab targets platelet-derived growth factor receptor alpha (PDGFRα) a cell surface protein often over-expressed in STS.

The aim of the trial is to evaluate the safety, pharmacokinetics, biodistribution and dosimetry, and establish the optimal dose of TLX300-CDx in patients with advanced STS, prior to therapeutic studies, based on a theranostic approach. As part of the study, it is also expected that the patient dosimetry and target expression characteristics will inform the final selection of therapeutic radionuclide for this candidate, in conjunction with currently active non-clinical radiation biology studies.

Telix intends to develop a novel targeted radionuclide therapy, specific for PDGFRα, which could be used to treat patients with STS. Telix holds the exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab, which was originally developed by Eli Lilly and Company (Lilly).

Professor Rodney Hicks AM, Founder, Chair, and Chief Medical Officer at MTIC, and Principal ZOLAR Investigator, said, "Sarcomas are individually very rare and they can arise from a variety of different tissues. Unfortunately, they tend to respond rather poorly to chemotherapy. While localized STS generally responds to radiotherapy, it is challenging to treat once it has spread. Targeted radionuclide therapy, which targets cancer cells throughout the body, is therefore an attractive option to treat disseminated disease. At MTIC, we're fortunate to be the first site validating this investigational agent as a precision diagnostic and to inform the design of future therapeutic studies."

Dr. David N. Cade, Telix Group Chief Medical Officer, added, "We are pleased that a first patient has been imaged in the first-in-human ZOLAR trial, which is designed to inform both the potential efficacy (dosimetry) and safety profile of this research candidate as a therapeutic, based on a theranostic approach. We would like to thank Professor Hicks and his team at MTIC for their commitment to addressing unmet medical need in STS, as well as the patients who will contribute to this important trial."

TLX300-CDx has not received a marketing authorization in any jurisdiction.

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