The U.S. Food and Drug Administration (FDA) has given the go-ahead to Blue Earth Therapeutics to conduct a clinical study of its radiopharmaceutical labeled with lutetium-177 (Lu-177) for treatment of metastatic, castrate-resistant prostate cancer (mCRPC).
Called LU-177 rhPSMA-10.1, the radiopharmaceutical will be used in a phase I/II open-label, multicenter trial that will look at the safety, tolerability, radiation dosimetry, and anti-tumor activity of the radiohybrid prostate-specific membrane antigen (rhPSMA) technology, which is intended to target prostate cancer lesions with elevated doses of radiation.
Phase I of the study will be conducted at clinical sites in the U.S. and will examine the impact of Lu-177 rhPSMA-10.1 in patients with PSMA-positive mCRPC which has progressed after previous treatment. Results from that phase will be used to determine the recommended treatment regimen to be trialed in phase II, which will expand testing to additional sites in the U.S. and sites in Europe.
