FutureChem is pushing ahead with its prostate cancer radiopharmaceutical FC705, moving the candidate into a phase 3 trial in Korea to assess its potential in metastatic castration-resistant prostate cancer (mCRPC).

The study, set to enroll 94 patients, will be conducted at eight hospitals in the Seoul metropolitan area, including Seoul St. Mary’s Hospital. FutureChem is testing FC705 in combination with standard therapy, comparing its efficacy and safety to standard treatment alone. Key endpoints include radiographic progression-free survival (rPFS), objective response rate (ORR), and disease control rate (DCR).

FC705 targets prostate-specific membrane antigen (PSMA) and carries the radioisotope lutetium-177 (177Lu). The drug is designed to extend circulation time in the bloodstream through an albumin binder, potentially enhancing its therapeutic impact.

With radioligand therapy gaining momentum globally, FutureChem is positioning FC705 as a domestic alternative in Korea, where patients have largely relied on imported treatments. To strengthen its case, the company is tweaking its dosing regimen for phase 3, shifting from six doses to four doses of 100 millicuries every eight weeks, a move driven by positive phase 2 results.

That trial saw 60 percent of patients achieve a PSA response—defined as a 50 percent or greater drop in prostate-specific antigen (PSA) levels—even after progressing on second-generation hormonal therapy and taxane-based chemotherapy. Three patients achieved complete PSA clearance

Unlike previous radioligand therapies, FutureChem said FC705 will incorporate PSMA PET/CT imaging as a composite efficacy assessment tool, a first for prostate cancer radiopharmaceuticals. The company says it will release interim data as soon as possible, focusing on rPFS and other key efficacy markers.