SOFIE Biosciences Initiates Phase 3 Trials for [18F]FAPI-74 PET Tracer in Gastroesophageal and Pancreatic Cancers
核心洞察
SOFIE Biosciences (搜索) has dosed the first patient in its FAPI (搜索)-GO Phase 3 trial evaluating [18F]FAPI-74 PET/CT for detecting metastatic disease in gastroesophageal cancers, marking a significant milestone in FAPI-based diagnostics.
The company launched a second Phase 3 study, FAPI (搜索)-PRO, in December 2025 to assess [18F]FAPI-74's clinical utility in pancreatic ductal adenocarcinoma (搜索) patients.
Previous Phase 2 results demonstrated promising efficacy with [18F]FAPI-74 showing 100% positive predictive value for detecting FAP (搜索)-expressing cells and 94% positive predictive value for GI malignancies.
SOFIE Biosciences (搜索) has achieved a significant milestone in radiopharmaceutical development by dosing the first patient in its Phase 3 clinical trial evaluating [18F]FAPI-74, a fluorine-18 labeled PET tracer targeting Fibroblast Activation Protein (搜索) (FAP (搜索)) for cancer diagnostics. The first dose was administered at RadNet in Los Angeles, marking the beginning of the FAPI (搜索)-GO trial for gastroesophageal cancers.
"We are proud of this milestone in the continuing clinical development of FAPI (搜索)," said Patrick Phelps, President and CEO of SOFIE Biosciences (搜索). "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."
Dual Phase 3 Program Targets Multiple Cancer Types
The company has launched two complementary Phase 3 studies. The FAPI (搜索)-GO (FAPI in Gastroesophageal Oncology) trial is a multi-site, open-label, non-randomized, single dose study designed to assess the clinical utility of [18F]FAPI-74 PET/CT in detecting metastatic disease in adults with gastroesophageal cancer (搜索). The study plans to enroll 200 subjects across 18 sites over a 24-month period, with primary endpoints focused on sensitivity and specificity for detection of distant metastatic disease (M1).
The second Phase 3 study, FAPI (搜索)-PRO (FAPI in Precision Imaging of Pancreatic Cancer), was activated on December 11, 2025. This trial will evaluate [18F]FAPI-74's clinical utility in detecting metastatic disease in adults with Pancreatic Ductal Adenocarcinoma (搜索) (PDAC (搜索)). SOFIE has activated two sites initially and plans to activate 16 additional sites nationwide over the next seven months to support both studies.
Strong Phase 2 Foundation
The Phase 3 program builds on promising Phase 2 results in gastrointestinal cancers, where [18F]FAPI-74 demonstrated 100% positive predictive value in detecting FAP (搜索)-expressing cells and 94% positive predictive value in detecting GI oncologic malignancies. These results provided the clinical foundation for advancing the compound into pivotal trials.
"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 (搜索)-expressing cells and 94% positive predictive value in detecting GI oncologic malignancies," according to SOFIE's announcement.
Novel Diagnostic Approach Through Tumor Microenvironment
[18F]FAPI-74 represents the lead fluorine-18 radiolabeled PET tracer in the FAPI (搜索) family of compounds, which target Fibroblast Activation Protein (搜索) highly expressed in cancer-associated fibroblasts across several tumor entities. The compound has demonstrated favorable dosimetry, avidity, safety, and a biodistribution profile amenable to detection of FAP (搜索)-expressing cells in patients with various cancers.
"FAPI (搜索)-74 is an exciting new advanced PET tracer," said Dr. Judith Rose, 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."
The quinoline-based PET tracers that act as FAP (搜索) inhibitors were originally developed by the team at Heidelberg University Hospital and have shown encouraging results in pre-clinical and clinical studies. FAPI (搜索) represents an important diagnostic entity that can be deployed alone or in combination with other tumor-targeting therapies such as chemotherapy, immunotherapy, radiation, or cell-based therapies.
Strategic Partnerships Drive Clinical Execution
The trials are being conducted through strategic partnerships with RadNet, Helios Clinical (搜索), and The Oncology Institute of Hope and Innovation (搜索). RadNet's national network of 407 owned and operated outpatient imaging centers provides the infrastructure for multi-site trial execution, while Helios Clinical's embedded approach to clinical trials in real-world care settings streamlines study operations.
Sherly Mosessian, Chief Scientific Officer at SOFIE, expressed satisfaction with the program's progress, stating, "I could not have asked for a better way to end 2025. Very proud of our team and thankful for our collaborators."