Key Findings
Preliminary data from the Phase 1 dose-escalation study of [ 225 Ac]Ac-FL-020 indicate significant prostate-specific antigen (PSA) decline in patients with metastatic castration-resistant prostate cancer (mCRPC). In lutetium-177-naive patients at dose levels 6 to 8 MBq, 100% achieved PSA50, 88.9% achieved PSA80, and 66.7% achieved PSA90. For lutetium-177-exposed patients at the same dose levels, PSA50 was achieved by 75%, PSA80 by 62.5%, and PSA90 by 25%.
Technical Details
The study evaluated 18 patients receiving doses of 6, 7, and 8 MBq, with 17 evaluable for PSA response. Safety data from a population of 39 patients showed no dose-limiting toxicities or deaths related to the study drug. Reported treatment-related serious adverse events included anemia, nausea, and thrombocytopenia, while no serious renal or hepatobiliary adverse events occurred. Xerostomia was predominantly Grade 1, with no Grade 3 cases. Notably, one patient who previously showed progressive disease on lutetium-177 therapy achieved a complete response via PSMA-PET imaging after two cycles of [ 225 Ac]Ac-FL-020 at 7 MBq.
Background & Context
[ 225 Ac]Ac-FL-020 is a PSMA-targeted alpha radiopharmaceutical developed using the proprietary UniRDC™ platform. It consists of a PSMA-targeting peptide labeled with actinium-225, designed for high tumor uptake and rapid clearance from normal tissue. The U.S. FDA has granted the compound Fast Track Designation for the treatment of mCRPC.
Significance & Outlook
The current safety profile has supported dose escalation through 10 MBq. Full-Life Technologies plans to initiate a Phase 2 dose optimization study, randomizing patients to two dosing regimens in accordance with recent FDA draft guidance on radiopharmaceutical dose optimization. The company aims to define the optimal dose and schedule while assessing the durability of response for both lutetium-177-naive and exposed patient populations.
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