Another defining moment for SOFIE Biosciences!

Last Friday, November 14, 2025, FAPI-GO, SOFIE’s [18F]FAPI-74 Phase 3 study in gastroesophageal cancers, officially went live!  The first site, a collaboration with Helios Clinical Research and RadNet, has been activated and is ready to enroll patients.  SOFIE plans to activate 18 total sites across the country over the next seven months.

The FAPI-GO study will evaluate [18F]FAPI-74 as a diagnostic tool in patients with gastroesophageal cancers, focusing on sensitivity and specificity of detection of metastatic disease. Launch of this trial follows the promising results of our Phase 2 study in GI cancers where [18F]FAPI-74 showed 100% positive predictive value in detecting FAP-expressing cells and 94% positive predictive value in detecting GI oncologic malignancies.

SOFIE is thankful to our valued clinical partners and our hard-working team for their commitment to helping us reach this point.  We are especially grateful to our patients who bring purpose to our efforts.

For more info on FAPI-GO (NCT07217704), visit the study page on ClinicalTrials.gov.

SOFIE is launching a second Phase 3 study, FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer), starting December 2025, focused on Pancreatic Ductal Adenocarcinoma (PDAC).