Radiopharm Theranostics doses first patient in prostate cancer clinical study

Radiopharm Theranostics (ASX:RAD) has dosed the first patient in its phase one clinical study of a candidate being evaluated for the treatment of advanced prostate cancer. The clinical-stage biopharm company’s first-in-human trial is testing RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161.

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The phase one trial is studying the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer.

Radipharm’s CEO and managing director, Riccardo Canevari, said the dose escalation study is designed to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) for expansion.

“Dosing the first patient in our phase one study of RAD 402 marks an important step forward for Radiopharm and for patients with advanced prostate cancer,” Mr Canevari said.

“RAD 402 is a differentiated, first-in-class, next-generation radiotherapeutic designed to selectively target KLK3-expressing tumours while minimising off-target exposure.

“With preclinical data demonstrating strong tumour uptake and minimal bone or marrow involvement, we are optimistic about its potential clinical profile.”

Proof-of-concept biodistribution studies of RAD 402 in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.

Mr Canevari said targeting KLK3 and leveraging the dual emission of Tb161 represents an innovative approach for radiotherapies in prostate cancer. According to Cancer Australia, there were an estimated 28,868 new cases of prostate cancer diagnosed in the country in 2025. It made up ~30% of all new male cancer cases diagnosed in 2025 and 13% of all male deaths from cancer last year.

Almost all prostate cancers are adenocarcinomas, which develop in the gland cells of the prostate. Other, rarer types include sarcomas, small cell carcinomas, neuroendocrine tumours and transitional cell carcinomas.

RAD is steady at 2cps through Friday so far. Mkt cap $70.88M.

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