Radiopharm Theranostics (ASX:RAD) has received approval from the Bellberry Human Research Ethics Committee to commence the Phase 1 clinical trial of its "177Lu-RAD202" therapy.
Before a clinical trial can begin in Australia, it must receive approval from an ethics committee. The trial can then be submitted to the Therapeutics Goods Administration (TGA).
Radiopharmaceuticals
Radiopharmaceuticals are radioactive drugs used for therapy or diagnostics — or both (aka "theranostics"). They contain a radioactive isotope that can be detected by imaging devices or used to destroy targeted cells, along with a "targeting vehicle" that guides the radionuclide to the cancer cell.
Radiopharm has a number of therapies under development. Its "177Lu-RAD202" drug consists of an isotope called Lutetium-177 and an antibody that's designed to bind to the HER2 protein receptor, which is overexpressed on cancer cells.
Lutetium-177 emits localised radiation to disrupt tumour cells while minimising damage to surrounding healthy tissue. It has a half-life of around 6.7 days — it decays quickly and doesn't remain in the body for long periods.
The trial
The trial, named HEAT (HER2 Antibody Therapy with Lutetium-177), will be an open-label, dose-escalation study designed to evaluate the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202. The study will be conducted at multiple sites across Australia, supported by GenesisCare CRO, a prominent oncology care provider.
The trial will target patients with solid tumours, including breast and gastric cancers, and will be first-in-human "basket" trial (a trial testing multiple types of cancers, instead of just one type of cancer).
RAD highlighted that prior studies demonstrated the safety and biodistribution of a similar compound (99mTc-labeled RAD202) and preclinical data showed tumour growth inhibition and extended survival time in models of HER2-positive cancers.
“We are thrilled to receive approval to proceed with our 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 that are refractory to or unable to tolerate current standard of care treatments.”
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