On December 29, 2025 SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, reported 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.
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"We are proud of this milestone in the continuing clinical development of FAPI," said Patrick Phelps, President and CEO, SOFIE Biosciences. "FAPI provides a different way to image and identify disease, by targeting cancer-associated fibroblasts in the tumor microenvironment. Dosing the first patient with [18F]FAPI-74 brings us one step closer to addressing vital areas of unmet need in gastric and esophageal cancers and realizing the promise of FAPI PET in precision medicine."
"FAPI-74 is an exciting new advanced PET tracer" said Judith Rose, MD, RadNet’s Director of PET/CT and Research. "RadNet’s experience in PET/CT clinical trials, combined with our national network of advanced imaging capabilities uniquely positions us to support oncology trials to transform cancer diagnosis and treatment. It is an honor to be in the position to have enrolled and imaged, in Los Angeles, the first patient in this important Phase 3 trial. We are looking forward to our ongoing partnership with SOFIE and our clinical partner Helios/The Oncology Institute. "
The FAPI-GO (FAPI in Gastroesophageal Oncology) trial 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 gastroesophageal cancer. The study is planned for 18 sites with an estimated enrollment of 200 subjects over a 24-month period.
The primary study endpoints are sensitivity and specificity for detection of distant metastatic disease (M1). For additional trial details, visit the study page on ClinicalTrials.gov (NCT07217704).
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. For additional trial details, visit the study page on ClinicalTrials.gov (NCT07217717).
ABOUT [18F]FAPI-74
[18F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer in the FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety, and a biodistribution profile amenable to detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners.
(Press release, Sofie Biosciences, DEC 29, 2025, View Source [SID1234661645])