SOFIE Biosciences, a US manufacturer and developer of radiopharmaceuticals, announced on Monday that the first patient has been dosed in one of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with GI cancers.

The FAPI-GO (FAPI in Gastroesophageal Oncology) trial, a multi-site, open-label, non-randomized, single dose study, is intended to evaluate the clinical utility of [18F]FAPI-74 PET/CT in the detection of metastatic disease in adults with gastroesophageal cancer. SOFIE is planning to conduct the study with 200 participants at 18 sites over a 24-month period.

Primary study endpoints are sensitivity and specificity for detection of distant metastatic disease (M1).

The second Phase 3 study, FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer), starting December 2025, is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [18F]FAPI-74 PET/CT in the detection of metastatic disease in adults with Pancreatic Ductal Adenocarcinoma.