SOFIE Biosciences has dosed the first patient in the second of its two Phase III clinical trials assessing 18F-FAPI-74, a fluorine-18 labelled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a diagnostic imaging agent for Pancreatic Ductal Adenocarcinoma (PDAC).

The Phase III study, titled FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer), is a multi-site, open-label, non-randomised, single-dose trial evaluating the clinical utility of 18F-FAPI-74 PET/CT in detecting distant metastatic disease in adults with PDAC. The trial is expected to enrol approximately 200 patients across 18 sites over a 24-month period. The primary endpoints are sensitivity and specificity in identifying distant metastases (M1).

According to Philipp Czernin, Chief Business Officer, SOFIE Biosciences, the initiation of patient dosing marks a milestone in evaluating FAPI-based imaging in oncology, particularly for improving staging accuracy in pancreatic cancer. Earlier Phase II data and investigator-initiated studies have indicated potential benefits in disease staging.

Dr. Gary Ulaner, Hoag Family Cancer Institute and University of Southern California, noted that the tracer’s sensitivity could support improved staging and treatment selection in newly diagnosed PDAC patients.

The companion Phase III study, FAPI-GO (FAPI in Gastroesophageal Oncology), began in November 2025 and is assessing FAPI-74 PET/CT in adults with gastroesophageal cancers. The first patient in that trial was dosed on December 26, 2025.

18F-FAPI-74 is the lead fluorine-18 radiolabelled PET tracer within the FAPI compound family. It has demonstrated favourable dosimetry, safety and biodistribution in earlier studies, supporting its potential use in imaging FAP-expressing cells across multiple tumour types.

FAP is highly expressed in cancer-associated fibroblasts in several malignancies. Quinoline-based FAP inhibitors (FAPI), originally developed by researchers at Heidelberg University Hospital, have shown encouraging results in pre-clinical and clinical evaluations. FAPI-based imaging may be used alone or in combination with other cancer treatment modalities.

SOFIE Biosciences is focused on the development and delivery of radiopharmaceutical diagnostics and therapeutics, supported by its manufacturing and distribution network and theranostic pipeline.