Radiopharm’s HEAT Is On: First Patient Dosed in Pioneering HER2 Trial

In a significant milestone for homegrown biotech Radiopharm Theranostics (ASX:RAD), the company has officially kicked off human dosing in its first-in-human Phase 1 trial of 177Lu-RAD202, a radiotherapeutic aimed squarely at HER2-positive advanced cancers. Dubbed the ‘HEAT’ trial – an acronym more evocative of a Top Gun sequel than a clinical study – the program signals Radiopharm’s full evolution from R&D hopeful to clinical-stage contender.

The trial marks the first time patients have been dosed with RAD202, a radiolabelled nanobody targeting HER2, a well-established oncological villain expressed in breast, gastric, ovarian, pancreatic and bladder cancers, among others. The ‘open-label’ dose-escalation study will assess safety, tolerability, and initial signs of efficacy, while also hunting down the optimal dose to take into Phase 2.

"This milestone marks our transition to a clinical-stage company," said CEO and Managing Director Riccardo Canevari. “Despite progress in HER2-positive therapies, many patients still face progression or intolerable side effects. RAD202 could offer a more effective and tolerable alternative.”

The science behind the promise is no shot in the dark. A previous diagnostic trial using the same HER2-targeting nanobody – labelled with 99mTc instead of lutetium-177 – demonstrated both safety and tumour-specific uptake in ten HER2-positive breast cancer patients. This early proof-of-concept, combined with preclinical data showing therapeutic impact in HER2-positive xenograft models, laid the groundwork for the current HEAT study.

“We’re privileged to be the first site to administer 177Lu-RAD202,” said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at Perth’s St John of God Murdoch Hospital. “It opens up a novel therapeutic avenue for patients with aggressive tumours, many of whom are running out of options.”

The dosing event follows years of strategic development and underscores Radiopharm’s ambition to stake its claim in the burgeoning radiopharmaceuticals space – a field that’s rapidly heating up as oncologists seek out precision tools to target tumours without lighting up healthy tissues.

Radiopharm’s broader clinical program includes three other Phase 1 trials and one Phase 2, spanning an arsenal of radiopharmaceuticals based on peptides, small molecules, and monoclonal antibodies. The goal? Precision oncology with fewer trade-offs – and ideally, more durable responses.

Listed on both the ASX (RAD) and NASDAQ (RADX), Radiopharm remains one of the few Aussie biotech plays with a foot in the high-potential, high-complexity world of radiotheranostics – a field once considered niche but now squarely in the sights of big pharma.

For investors keen on oncology moonshots, Radiopharm’s HEAT trial could prove a thermometer worth watching. The company will need to demonstrate not only safety but also a compelling signal of efficacy to stand out in the increasingly competitive HER2 arena. Yet if the preclinical and diagnostic clues bear out, RAD202 might just turn up the temperature on standard care.