by
Gus Iversen, Editor in Chief | May 06, 2025
Blue Earth Therapeutics has launched a phase 2 clinical trial evaluating Lutetium (177Lu) rhPSMA-10.1 injection in patients with metastatic castration-resistant prostate cancer (mCRPC).
The trial builds on phase 1 data that indicated strong tumor targeting with limited uptake in healthy tissues.
The Oxford, United Kingdom-based radiopharmaceutical company announced that the first two patients have been dosed in the study, which aims to assess efficacy and safety across different dosing regimens. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in PSA levels, with additional measures including radiographic progression-free survival and overall safety.
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The trial is designed to test intensified dosing strategies, either through higher initial doses or by shortening intervals between doses early in the treatment cycle. Total administered radioactivity may reach up to 60GBq. This approach is intended to align with the FDA’s Project Optimus, which encourages dose optimization early in development to refine risk-benefit profiles.
“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," said David Gauden, CEO of Blue Earth Therapeutics. "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.”
The multicenter study is expected to enroll participants at up to 20 sites, with initial results anticipated in the first half of 2026.
Blue Earth Therapeutics, a subsidiary of Bracco Imaging, focuses on radiopharmaceutical therapies for cancer. Its rhPSMA technology was originally developed at the Technical University of Munich and is designed to target prostate-specific membrane antigen, a protein commonly expressed in prostate cancer cells.
According to recent estimates, there will be approximately 50,000 new cases of metastatic prostate cancer in the U.S. in 2025, with a five-year survival rate of just under 37%.
