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Blue Earth Therapeutics Initiates Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Lutetium (177Lu) rhPSMA-10.1 Injection in Metastatic Castrate Resistant Prostate Cance

  • (177Lu) rhPSMA-10.1 injection, engineered to improve delivery of radiation to cancer lesions, recently showed promising data in a phase 1 trial1
  • The goal of the phase 2 study is to further assess this improved profile, together with testing of optimised dosing regimens
  • First patients have received doses of (177Lu) rhPSMA-10.1 injection
  • 1st study results could be available as soon as H1 2026
Reno, Nevada (UroToday.com) -- Blue Earth Therapeutics announced further progress in the development of its radiohybrid, lutetium-labelled, PSMA targeted, investigational radioligand therapy, with enrolment of the first two patients in a Phase 2 clinical trial. The primary measure of efficacy in the study will be the proportion of patients achieving a ≥50% reduction in PSA levels, as well as assessing radiographic progression-free survival and patient safety (NCT05413850).

The study is testing multiple dosing regimens that focus on delivering higher radiation doses when tumor burden is usually highest, at the beginning of treatment. This approach contrasts to pivotal studies of earlier radioligand therapies where the same dose was administered in every cycle2 regardless of tumor burden. The study design aligns with the US FDA Project Optimus initiative, where the goal is that drug developers optimize dosing early in a product's development to deliver the best possible benefit risk profile.

Loading doses will be delivered by either a) giving a higher dose in the first two treatment cycles, or b) shortening the time between administration of the first three doses to three weeks from the usual six weeks. The study is also designed to test the clinical benefit of administration of high total doses of administered radioactivity, up to 60GBq. The Phase 1 data confirmed a high ratio of uptake in tumor tissues vs. uptake in healthy tissues such as kidneys and salivary glands.1

David Gauden DPhil, CEO of Blue Earth Therapeutics said, "This is an important step forward in the development of Lutetium (177Lu) rhPSMA-10.1 injection and builds on the strong data seen in the Phase 1 clinical trial. Commencement of treatment of patients at full intended therapeutic dosing levels provides a great opportunity to assess the benefit this therapy can bring to patients. With up to 20 sites enrolling patients, we expect to see first results from the study early next year. We are grateful to the physicians and patients of Biogenix Molecular in Florida, who have just recruited the first patients for the study."
  1. https://www.blueearththerapeutics.com/news
  2. NCT04647526, NCT05204927, NCT04720157, NCT04689828
Source: Blue Earth Therapeutics. (2025). Blue Earth Therapeutics: SNMMI Presentation of Results from Lutetium (177Lu) rhPSMA-10.1 Injection Phase 1 Clinical Trial [Press release]. https://www.blueearththerapeutics.com/news.