SOFIE Biosciences, a US-based developer and manufacturer of radiopharmaceuticals, has announced a major milestone: the first patient has been dosed in one of its two Phase 3 clinical trials of novel cancer imaging agent.
The company has basically tested [18F]FAPI-74, a fluorine-18 labelled radiopharmaceutical designed to target fibroblast activation protein (FAP) in gastrointestinal (GI) cancers.
“We are proud of this milestone in the continuing clinical development of FAPI,” said Patrick Phelps, President and CEO of 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.”
The FAPI-GO trial—short for FAPI in Gastroesophageal Oncology—is a multi-site, open-label, non-randomized, single-dose study evaluating the ability of [18F]FAPI-74 PET/CT to detect metastatic disease in adults with gastroesophageal cancer.
The study will run across 18 sites and enroll roughly 200 patients over 24 months, focusing on sensitivity and specificity for detecting distant metastatic disease.
“FAPI-74 is an exciting new advanced PET tracer,” said 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.
"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.”
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