A recent article highlights the positive Phase I data for 177Lu rhPSMA-10.1, a novel radioligand therapy being developed by Blue Earth Therapeutics for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The encouraging safety profile is based on radiation dosimetry findings from the trial, which enrolled patients in July. These findings revealed that tumors absorbed high radiation doses compared to the doses received by the kidneys and salivary glands. The ratio of tumor radiation to organ radiation observed with 177Lu rhPSMA-10.1 is considered compelling compared to data from earlier radioligand therapies.
Blue Earth Therapeutics is moving forward with a Phase II trial for 177Lu rhPSMA-10.1 later this year. The trial is expected to enroll approximately 70 patients at about 15 sites in the US and Europe. This next phase of the trial will evaluate a higher total injected radioactivity than recent Phase III trials for other agents, front-load the administered radioactivity, and extend the treatment duration. These aspects of the trial design are based on the idea that fixed dosing at fixed intervals is likely not optimal for this type of therapy. The company believes that front-loading radioactivity and extending time on therapy may lengthen the time to disease progression and lead to the best possible outcomes for patients in a future pivotal trial.
Final analysis of the Phase I trial is still ongoing, and the company expects to present the full results at a scientific meeting in 2025.

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