SOFIE Biosciences Announces First Patient Dosed in [18F]FAPI-74 Phase 3 Study

First dose at RadNet, in partnership with Helios Clinical and The Oncology Institute of Hope and Innovation, in FAPI-GO trial for gastroesophageal cancers

A second trial focused on PDAC, FAPI-PRO, launched December 2025

DULLES, Va., Dec. 29, 2025 /PRNewswire/ -- SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, today announced 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.

"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.

ABOUT FAPI

Fibroblast activation protein is highly expressed in cancer-associated fibroblasts across several tumor entities. Quinoline-based PET tracers that act as FAP inhibitors (FAPI), developed by the team at Heidelberg University Hospital (UKHD), have shown encouraging results in pre-clinical and clinical studies. FAPI is an important diagnostic or therapeutic entity that can be deployed alone or in combination with other tumor-targeting therapies such as chemo, immunology, radiation, or cell-based therapies whose function may be otherwise blunted by the tumor stroma.

ABOUT SOFIE

SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high-value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, please visit https://sofie.com/ or contact [email protected].

ABOUT RADNET, INC.

RadNet, Inc. is a leading provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 407 owned and/or operated outpatient imaging centers. RadNet's markets include Arizona, California, Delaware, Florida, Maryland, New Jersey, New York and Texas. In addition, RadNet provides radiology information technology and artificial intelligence solutions marketed under the DeepHealth brand, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry. Together with contracted radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has over 11,000 team members. https://radnet.com

ABOUT HELIOS CLINICAL

Helios Clinical is a leading clinical trial network dedicated to accelerating access to innovative therapies through high-quality, patient-centered research. By embedding clinical trials into real-world care settings, Helios streamlines study operations and enables sponsors and providers to efficiently deliver tomorrow's treatments to patients who need them most.

In partnership with The Oncology Institute of Hope and Innovation, a nationally recognized leader in community-based oncology care, Helios Clinical is expanding access to cutting-edge cancer clinical trials. Together, the organizations are committed to advancing oncology research, improving outcomes, and bringing innovative therapies closer to patients through excellence in care and collaboration. Oncology Research - Helios Clinical Research

SOFIE BIOSCIENCES Media Contact:
Janna Laton
Director of Product Launch – FAPI
[email protected] 

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SOURCE Sofie Biosciences