SOFIE shared a post on LinkedIn:
“FAPI-PRO is a GO!
SOFIE is proud to announce FAPI-PRO, our [18F]FAPI-74 Phase 3 study on Pancreatic Ductal Adenocarcinoma (PDAC), is officially live and ready to enroll patients. The study was activated on December 11, 2025, closely following the start of FAPI-GO, our [18F]FAPI-74 Phase 3 study on gastroesophageal cancers. SOFIE has activated two sites and plans to activate 16 additional sites nationwide over the next seven months in support of both studies.
The FAPI-PRO study will evaluate [18F]FAPI-74 as a diagnostic tool in patients with pancreatic ductal adenocarcinomas, 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 could not accomplish this milestone without our esteemed clinical partners and dedicated team to see us through to launch and beyond. Importantly, we are grateful to our patients for their time and trust in our efforts.
For more information on FAPI-PRO (NCT07217717), visit the study page on ClinicalTrials.gov.
For more information on FAPI-GO (NCT07217704), visit the study page on ClinicalTrials.gov.
For more information on FAPI: [email protected]”
Sherly Mosessian, Chief Scientific Officer at SOFIE, shared this post, adding:
“I could not have asked for a better way to end 2025. Very proud of our team and thankful for our collaborators.”
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