Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) has announced initiation of a phase 1 clinical trial (NCT07414940) evaluating actinium (225Ac) rhPSMA-10.1 injection, an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical for the treatment of patients within clinical trials in metastatic castrate‑resistant prostate cancer (mCRPC).
The study is sponsored by UCL and is being conducted at UCL Hospital, London. Blue Earth Therapeutics is providing funding and supply of investigational drug product.
This phase 1 study is designed to evaluate the safety and anti-tumour activity of actinium (225Ac) rhPSMA-10.1 injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy.
Results from the study are expected to characterise the side effects of actinium (225Ac) rhPSMA-10.1 injection and to inform dose selection for subsequent research.
Alpha-emitting radionuclides such as actinium-225 (225Ac) deliver a high amount of energy over a short distance in tissue, causing irreparable DNA damage to targeted cancer cells while aiming to limit exposure to surrounding healthy tissue.
When incorporated into a PSMA-targeting molecule such as rhPSMA-10.1, this approach is designed to deliver localised radiation directly to prostate cancer lesions, potentially offering a targeted treatment strategy for patients with advanced cancer.
Actinium (225Ac) rhPSMA-10.1 injection is the second clinical candidate in Blue Earth Therapeutics’ oncology pipeline, building on the company’s ongoing lutetium (¹⁷⁷Lu) rhPSMA‑10.1 injection clinical programme, which is currently in a phase 2 clinical trial.
Together, these programmes reflect the company’s work across both alpha‑ and beta‑emitting radiopharmaceutical therapies using its radiohybrid PSMA platform.
