Radiopharm (ASX:RAD) Secures Ethics Approval for First-in-Human Trial of RAD 402 in Prostate Cancer

2 min read | November 18, 2025 11:51 AM AEDT | By Sonal Goyal

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Radiopharm (ASX:RAD) Secures Ethics Approval for First-in-Human Trial of RAD 402 in Prostate Cancer — Image source: Company Update

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Highlights

The Bellberry Human Research Ethics Committee has approved Radiopharm to commence the Phase 1 First-in-Human trial of RAD 402.

RAD 402 is a KLK3-targeting monoclonal antibody radiolabelled with Tb-161 for prostate cancer treatment.

Preclinical biodistribution studies showed tumour targeting with limited marrow and bone uptake.

Supply agreements with Terthera and Cyclotek secure 161Tb production and radiolabelling for the trial.

Radiopharm Theranostics (ASX:RAD) has announced that the Bellberry Human Research Ethics Committee (HREC) has approved the launch of its First-In-Human (FIH) Phase 1 clinical trial of RAD 402. The trial will enrol patients with metastatic or locally advanced prostate cancer.

Mechanism and Design of RAD 402

RAD 402 is a humanised IgG1 antibody that is selectively taken up by prostate cells and binds with high affinity to Kallikrein Related Peptidase 3 (KLK3).

It is an anti-KLK3 monoclonal antibody that is radiolabelled with the radionuclide 161Tb for investigating its use in treating prostate cancer. Prostate Specific Antigen (PSA), which is encoded by the KLK3 gene, is widely used as a biomarker for identifying prostate cancer. KLK3 is found in prostate tissue and is also present in most prostate adenocarcinomas, including metastatic forms of the disease.

Preclinical Studies Support Clinical Transition

Preclinical proof-of-concept biodistribution studies conducted in mouse xenograft models demonstrated that RAD 402 achieved notable tumour targeting. The studies also showed limited uptake in bone and bone marrow, along with a hepatic excretion profile consistent with that of monoclonal antibodies.

Manufacturing and Supply Agreements in Place

The company had inked a supply agreement with Terthera in 2022 to produce Tb-161. In 2025, the company also signed an agreement with Cyclotek for radiolabelling RAD 402 with 161Tb. Together, these arrangements provide the materials required to initiate and conduct the Phase 1 First-In-Human study.

RAD shares were trading at AUD 0.023 per share during trading session on 18 November 2025.

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