St Bartholomew's Hospital and The James Cook University Hospital mark key UK expansion of the company’s Phase 2 mCRPC programme
Blue Earth Therapeutics today announced that the first patients in the UK have been administered with the investigational radiopharmaceutical therapy Lutetium (177Lu) rhPSMA-10.1 Injection in an ongoing Phase 2 clinical trial (NCT05413850) at St Bartholomew’s Hospital and The James Cook University Hospital. This milestone marks continued expansion of the clinical development programme for the company’s radiohybrid, lutetium-labelled, PSMA-targeted investigational radiopharmaceutical therapy in men with metastatic castration-resistant prostate cancer (mCRPC).
Dr Kenrick Ng, Medical Oncology Consultant, St Bartholomew’s Hospital, London, said: “Dosing one of the first patients in the UK in this Phase 2 study is an important milestone as we work to advance new therapeutic options for men with metastatic castration-resistant prostate cancer. Radiopharmaceuticals represent a promising area of investigation in this difficult-to-treat setting, and the team at our hospital is pleased to contribute to the generation of the clinical evidence needed to understand the potential of this investigational treatment.”
Dr Darren Leaning, Consultant Clinical Oncologist, The James Cook University Hospital, Middlesbrough, said: “Bringing this study to the UK is an important step in expanding access to complex radiopharmaceutical trials. Delivering studies of this kind requires close collaboration across clinical, research, and nuclear medicine teams, we at the James Cook Cancer Institute pride ourselves on bringing studies like this to our Teesside patients and we are pleased to be working with colleagues at other NHS trusts and the radiopharmaceutical industry to support the generation of high-quality clinical data for patients with advanced prostate cancer.”
The milestone of administering the first doses to patients in the UK highlights growing momentum for the Lutetium (177Lu) rhPSMA-10.1 Injection clinical programme. Other sites in the UK are actively screening patients for this study. Activation of UK clinical sites broadens the study’s international footprint and supports the generation of high-quality evidence across multiple healthcare settings. The expansion supports ongoing efforts to evaluate novel dosing strategies and contributes to the future global development of this PSMA-targeted radioligand therapy.
David Gauden, CEO of Blue Earth Therapeutics, said: “Dosing the first patients in the UK marks a pivotal step in our mission to advance radiopharmaceutical treatments for prostate cancer. With our company being headquartered in the UK, this milestone reflects our commitment to the UK’s life sciences vision to accelerate clinical research and translate innovation into meaningful patient benefit. We are proud to work in partnership with UK investigators, the NHS and patients to help strengthen the UK’s position as a global leader in life sciences excellence.”
The Phase 2 is evaluating multiple strategies to optimise dosing by delivering higher radiation doses during the early treatment cycles when tumour burden is typically greatest. This approach differs from earlier pivotal studies of radioligand therapies where fixed dosing was applied uniformly across all cycles². The study design aligns with the US FDA’s Project Optimus initiative, which encourages dose optimisation early in development to support a favourable benefit–risk profile.
Front loading of radioactivity in Phase 2 will be achieved either by (a) giving higher radioactivity injections in the first two cycles or (b) shortening the interval between the first three injections of radioactivity from six weeks to three weeks. The study also evaluates the potential clinical benefit of delivering higher cumulative administered radioactivity, up to 60 GBq. As part of the study design, the primary measure of efficacy will be the proportion of patients achieving a ≥50% reduction in prostate-specific antigen (PSA) levels alongside a detailed assessment of safety and capturing radiation dosimetry data for all patients.