Radiopharm Theranostics (ASX:RAD) received approval from the Belberry Human Research Ethics Committee to begin a Phase 1 clinical trial of 177Lu-RAD202 therapy.

Ethics committee approval is required before a clinical trial can begin in Australia. The trial can then be submitted to the Therapeutic Goods Administration (TGA).

radiopharmaceutical

A radiopharmaceutical is a radioactive drug used for treatment or diagnosis, or both (also known as a “therapeutic agent”). These include a radioisotope that can be detected by an imaging device or used to destroy target cells, and a “targeting vehicle” that directs the radionuclide to the cancer cells.

Radiopharm has a number of treatments in development. The company’s 177Lu-RAD202 drug consists of an isotope called lutetium-177 and an antibody designed to bind to the HER2 protein receptor, which is overexpressed in cancer cells.

Lutetium-177 emits localized radiation to destroy tumor cells while minimizing damage to surrounding healthy tissue. It has a half-life of approximately 6.7 days, decays quickly, and does not remain in the body for long.

trial

The study, named HEAT (HER2 Antibody Therapy with Lutetium-177), was an open-label, dose-escalation study designed to evaluate the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202. It will be. The study will be supported by leading oncology care provider GenesisCare CRO and will be conducted at multiple sites across Australia.

The trial will target patients with solid tumors, including breast and stomach cancer, and will be a first-in-human “basket” trial (a trial that tests multiple types of cancer rather than just one).

RAD notes that previous studies have demonstrated the safety and biodistribution of a similar compound (99mTc-labeled RAD202), with preclinical data showing tumor growth inhibition and survival prolongation in HER2-positive cancer models. emphasized.

“We are very pleased to have received approval to proceed with the Phase 1 FIH basket trial in Australia,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “RAD 202 has the potential to address an unmet treatment gap in HER2-positive metastatic patients who are refractory or intolerable to current standard treatments.”

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