Theranostics Radiopharm (ASX:RAD) received approval from Bellberry’s Human Research Ethics Board to begin the Phase 1 clinical trial of its therapy “177Lu-RAD202.”
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 therapeutic or diagnostic purposes – or both (called “theranostics”). They contain a radioactive isotope that can be detected by imaging devices or used to destroy targeted cells, as well as a “targeting vehicle” that guides the radionuclide to the cancer cell.
Radiopharm has a number of therapies in development. Its drug “177Lu-RAD202” consists of an isotope called Lutetium-177 and an antibody designed to bind to the protein receptor HER2, which is overexpressed on cancer cells.
Lutetium-177 emits localized radiation to disrupt tumor cells while minimizing damage to surrounding healthy tissue. Its half-life is approximately 6.7 days: it breaks down quickly and does not stay in the body for long.
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, with support from GenesisCare CRO, a leading oncology care provider.
The trial will target patients with solid tumors, including breast and stomach cancers, and will be the first “basket” trial in humans (a trial testing multiple types of cancer, instead of just one type of cancer).
RAD noted that previous studies demonstrated the safety and biodistribution of a similar compound (99mTc-labeled RAD202) and that preclinical data showed inhibition of tumor growth and prolonged survival time in cancer models. HER2-positive.
“We are delighted to receive approval to continue our Phase 1 FIH basket trial in Australia,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “RAD 202 has the potential to fill an unmet gap in the treatment of HER2-positive metastatic patients who are refractory or unable to tolerate current standard therapies. »
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