FutureChem has initiated a Phase 3 clinical trial in South Korea to assess the efficacy of its new radiopharmaceutical, FC705, for treating metastatic castration-resistant prostate cancer (mCRPC). The study will involve 94 patients across eight hospitals in the Seoul metropolitan area, including Seoul St. Mary’s Hospital.

FC705 is a PSMA-targeted radiopharmaceutical carrying the radioisotope Lutetium-177 (177Lu). It is designed with an albumin-binding ligand to extend circulation time in the bloodstream, potentially enhancing its therapeutic impact.

In the Phase 2 trial, 60% of patients achieved a ≥50% reduction in PSA levels, even after disease progression following second-generation hormonal therapies and taxane-based chemotherapy. Notably, three patients experienced complete PSA elimination.

Unlike previous radioligand therapies, FC705 will incorporate PSMA PET/CT imaging as a composite tool to evaluate treatment efficacy, a first for prostate cancer radiopharmaceuticals. FutureChem aims to release interim data soon, focusing on radiographic progression-free survival (rPFS) and other key efficacy markers.

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