FCS Achieves Milestone with First Phase 1 Radioligand Trial Patient

Florida Cancer Specialists & Research Institute (FCS) has reached an important milestone in its clinical research program with the successful dosing of the first patient in the statewide practice’s history in a Phase 1 radioligand therapy clinical trial.

The patient, who is being treated for small-cell lung cancer, received the investigational therapy at FCS’ Sarasota Drug Development Unit (DDU). The study involves Abdera’s DLL3 actinium radioligand, an emerging targeted therapy designed to deliver radiation directly to cancer cells while minimizing exposure to surrounding healthy tissue.

This complex early-phase study required a collaborative, multispecialty effort including teams from FCS and Sarasota Memorial Hospital, where specialized equipment and facilities were used to support the dosing process and extensive same-day specimen analysis. The protocol included full-day hot lab procedures, specimen processing and imaging using single-photon emission computed tomography (SPECT), making the treatment process significantly more involved than a typical Phase 1 clinical trial visit.

According to the research team, the work required for this single patient was equivalent to the operational effort typically associated with approximately five Phase 1 trial patients, highlighting the complexity and coordination required to successfully deliver radioligand therapy in a clinical trial setting.

The milestone reflects FCS’ continued expansion of its early-phase research capabilities and its commitment to bringing innovative therapies to patients in the community setting.

The successful initiation of this study also underscores the strength of FCS’ research program, which offers more than 180 early- and late-phase clinical trials annually, positioning FCS to continue advancing novel treatment approaches.