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Radiopharm Theranostics Ltd (ASX:RAD) has received ethics approval to begin its Phase 1 trial to assess the safety and initial clinical activity of candidate Lu-RAD202 for the treatment of breast and gastric cancers.
The approval was received from the Belberry Human Research Ethics Committee (HREC) and will open the door to Radiopharm beginning its First In-Human (FIH) Phase 1 therapeutic clinical study of 177Lu-labelled RAD 202.
The latter is being developed to treat solid tumours that express human epidermal growth factor receptor 2 (or HER2), a transmembrane tyrosine kinase receptor that stimulates cell proliferation, differentiation, and survival.
It is often overexpressed in a range of tumours, including gastric, breast, bladder, pancreatic, and gynecological ones.
RAD202 is a single-domain monoclonal antibody (sdAb) that targets HER2, and this open-label trial is also a dose escalation trial of Lu-RAD202, with recruitment for it to be run across Australia.
CEO and managing director Riccardo Canevari said he was pleased the approval process had been successful, and the trial could now progress as planned.
“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,” he explained today.
“With RAD 202, we hope to provide an alternative strategy that can improve clinical outcomes for patients with HER2-positive advanced cancers, while potentially preserving their quality of life.”
Radiopharm shares have risen following the news. At 10:53 AEDT, they traded at 2.5 cents – a rise of 19.05% since market open.
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