New Cancer Imaging Agent Enters Phase 3 Trial for Pancreatic Cancer

DULLES, Va. – February 11, 2026 – By Amanda Clark

SOFIE Biosciences, a U.S.-based developer of radiopharmaceuticals, announced today that the first patient has been dosed in a pivotal Phase 3 clinical trial for a new cancer imaging agent, a significant milestone in the fight against pancreatic cancer. The trial, named FAPI-PRO, will evaluate the effectiveness of [18F]FAPI-74, a novel diagnostic tool designed to more accurately detect the spread of Pancreatic Ductal Adenocarcinoma (PDAC), one of the most lethal malignancies.

The first dose was administered at the Hoag Family Cancer Institute in California, marking the start of a multi-site study that aims to enroll 200 patients over the next two years. This development offers a new glimmer of hope for a disease where early and accurate detection is paramount but notoriously difficult to achieve.

"Dosing the first patient in our FAPI-PRO trial is a major step forward in the evaluation of FAPI as an oncological diagnostic tool," said Philipp Czernin, Chief Business Officer at SOFIE Biosciences, in a statement. "We undergo this trial encouraged by the results of our Phase 2 and independent academic investigator-initiated studies supporting [18F]FAPI-74's potential role in staging accuracy, which is especially needed for pancreatic cancer."

A New Frontier in Cancer Imaging

The technology behind [18F]FAPI-74 represents a fundamental shift in how doctors may visualize tumors. Unlike the most common PET scan agent, [18F]FDG, which tracks glucose metabolism, [18F]FAPI-74 targets a specific protein called Fibroblast Activation Protein (FAP).

FAP is a protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs), cells that form the structural scaffolding of tumors and can constitute up to 90% of a tumor's mass. These fibroblasts are critical for tumor growth, invasion, and metastasis. Crucially, FAP is abundant in many types of cancer—including pancreatic, gastroesophageal, breast, and lung—but is virtually absent in healthy adult tissues. This makes it an almost perfect target for precision imaging.

By binding to FAP, the [18F]FAPI-74 tracer essentially lights up cancerous lesions during a PET scan, providing a high-contrast image. Previous studies have suggested this method can achieve a superior tumor-to-background ratio, creating clearer images and potentially revealing small metastatic sites that other imaging methods might miss. The agent’s favorable safety profile, rapid clearance from healthy tissues, and strong binding affinity are key characteristics that have propelled it into late-stage trials.

"The potential sensitivity of [18F]FAPI-74 PET makes its availability to stage patients with newly diagnosed pancreatic ductal adenocarcinoma attractive to patients and clinicians alike," commented Dr. Gary Ulaner of the Hoag Family Cancer Institute and USC. "The whole team, including surgeons and oncologists, are enthusiastic about using [18F]FAPI-74 PET to help select the best initial treatments."

Tackling a Notoriously Difficult Disease

Pancreatic Ductal Adenocarcinoma carries a grim prognosis, largely because it is so difficult to diagnose early. Over 80% of patients are diagnosed only after the disease has advanced locally or spread to distant organs, at which point surgery—the only potential cure—is no longer an option. Current imaging modalities like CT and MRI often struggle to detect small tumors or accurately stage the disease.

The FAPI-PRO trial is designed to address this critical unmet need. Its primary goals are to measure the sensitivity and specificity of [18F]FAPI-74 PET/CT for detecting distant metastatic disease. The results could determine if this new agent can provide surgeons and oncologists with a more accurate roadmap of a patient's cancer, enabling better-informed decisions about whether to proceed with aggressive surgery or opt for systemic therapies like chemotherapy.

This trial is the second of two parallel Phase 3 studies launched by SOFIE. Its partner trial, FAPI-GO, began in late 2025 and is evaluating the same imaging agent for patients with gastroesophageal cancers. That trial also followed promising Phase 2 data which showed a high predictive value for detecting cancerous malignancies.

SOFIE's Strategic Push into Theranostics

The dual Phase 3 trials signal a major strategic push by SOFIE Biosciences to solidify its leadership in the rapidly growing field of theranostics—an approach that combines diagnostics and therapeutics, often using the same molecular target. While [18F]FAPI-74 is a diagnostic agent, the FAP target itself holds immense promise for therapy. A diagnostic that can identify FAP-positive tumors could pave the way for future therapeutic agents designed to attack those same cells.

This ambitious clinical program is backed by significant financial investment and strategic partnerships. In 2020, the company secured a $27.4 million Series C financing led by Jubilant Pharma, a move aimed at expanding its production capacity and advancing the FAPI program. More recently, in 2024, SOFIE received a substantial growth investment from private equity firm Trilantic North America.

Furthermore, SOFIE has established a crucial partnership with GE HealthCare to develop, manufacture, and commercialize FAP-targeted diagnostics. This collaboration leverages SOFIE's intellectual property with GE HealthCare's global reach, creating a powerful engine for bringing this technology to market if the trials prove successful.

The Pan-Cancer Potential of FAP Targeting

While the immediate focus is on pancreatic and gastroesophageal cancers, the implications of FAP-targeting technology extend far beyond these trials. The widespread presence of FAP across a broad spectrum of solid tumors positions FAPI-based agents as a potential "pan-cancer" tool, capable of transforming oncological imaging for numerous cancer types.

The significance of this target has not gone unnoticed. The field is becoming a hotbed of innovation, with companies like Telix Pharmaceuticals and Clarity Pharmaceuticals also developing their own FAP-targeted radiopharmaceuticals for both imaging and therapy. This competitive interest, rather than diluting the opportunity, validates the immense clinical potential of FAP as a central target in modern oncology.

The successful development and approval of a FAP-targeted PET tracer like [18F]FAPI-74 could represent one of the most significant advances in nuclear medicine in decades. By providing a clearer picture of the enemy, this technology holds the potential to refine treatment strategies, improve patient selection for clinical trials, and ultimately offer a better chance for patients battling some of the world's most challenging cancers.