Promising Results Reported by Full-Life Technologies for FL-020 in Phase 1 Study on Prostate Cancer

Significant Milestones in Prostate Cancer Treatment: FL-020's Phase 1 Results

Full-Life Technologies, a forward-thinking player in the radiopharmaceutical sector, has recently shared promising preliminary findings from its Phase 1 dose-escalation study of [225Ac]Ac-FL-020. This investigational medication, aimed at targeting prostate-specific membrane antigen (PSMA), is being evaluated specifically for its efficacy in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The results were revealed during the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, showcasing the potential of this innovative medication.

The ongoing study, as of October 9, 2026, involved 18 participants taking doses of 6, 7, and 8 megabecquerel (MBq) of the experimental drug. The findings indicated no dose-limiting toxicities, which is a significant consideration in drug development. Instead, adverse effects were largely manageable, with most xerostomia (dry mouth) cases rated as Grade 1.

Crucially, the study revealed promising levels of Prostate-Specific Antigen (PSA) decline in both those who had no prior exposure to lutetium-177 and those who had. The results showed that 100% of lutetium-177-naïve patients achieved at least a 50% reduction in PSA, known as PSA50, while 88.9% achieved PSA80 and 66.7% achieved PSA90. For patients previously treated with lutetium-177, 75% reached PSA50 and 62.5% reached PSA80, albeit with lower figures for PSA90.

Dr. Debora Barton, Chief Medical Officer at Full-Life, expressed optimism regarding FL-020's potential, particularly for those whose cancer has progressed following traditional treatments. She emphasized the importance of their observations, especially a complete response noted via PSMA-PET imaging after just two cycles of treatment at a 7 MBq dosage in one patient, whose prior response to lutetium-177 was disease progression.

With great anticipation, Full-Life Technologies is set to initiate a Phase 2 study focusing on dose optimization, aligning with updated FDA guidelines for radiopharmaceutical treatments. Dr. Aaron R. Hansen, a medical oncology professor in Australia, reinforced the significance of the results, citing the substantial number of patients achieving meaningful PSA declines, indicating that FL-020 may fill critical gaps for mCRPC patients, ultimately enhancing their treatment options.

FL-020 is classified as a next-generation PSMA-targeted alpha radioconjugate, engineered to deliver high and prolonged tumor uptake while ensuring rapid removal from healthy tissues, a combination that aims to improve treatment efficacy. The FDA has already granted FL-020 Fast Track Designation for its treatment in mCRPC, signaling the regulatory body's recognition of its potential in combating this challenging disease.

Full-Life Technologies is engaged in numerous clinically-advanced programs, illustrating the breadth of its commitment to advancing cancer therapies. These include developing multiple targeted radioconjugate options that may revolutionize the treatment landscape for advanced cancers across various indications.

With the landscape of metastatic prostate cancer treatments evolving, the results from Full-Life's studies herald hope for patients and clinicians alike in the pursuit of more effective therapies to combat this formidable disease.