Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

NCT05641896 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 18FFAPI-2023P2
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 6

Brief Summary

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The \[18F\]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

Conditions

Gastric Cancer; Gastrointestinal Cancers; Cholangiocarcinoma; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma; Hepatocellular Carcinoma

Keywords

Fibroblast Activation Protein; Fibroblast Activation Protein Inhibitor; FAPI; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (3)

• Positive Predictive Value (PPV) of [18F]FAPI-74 PET Imaging Using Immunohistochemistry (IHC)

  The positive or negative status according to \[18F\]FAPI-74 PET imaging was determined based on a prespecified cut-off value for each appropriate test as determined by the clinician. Positivity was evaluated using the following prespecified H-score thresholds: \> 50: Overall positive versus negative expression; \> 100: Moderate to high expression and \> 200: High expression only. The primary efficacy endpoint was the positive predictive value of \[18F\]FAPI-74 PET imaging, defined as the proportion of PET-positive results that were confirmed positive by IHC. PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.

  Day 1

• Sensitivity of [18F]FAPI-74 PET Imaging to Detect FAP-Expressing Cells, Using IHC

  Sensitivity was defined as the proportion of participants with IHC confirmed FAP-expressing cells who had a positive \[18F\]FAPI-74 PET result for the primary lesion. Sensitivity was calculated as A / (A + C), where A represents true positive findings and C represents false negative findings. Higher sensitivity indicates a greater ability of \[18F\]FAPI-74 PET to detect IHC confirmed FAP expression and a lower likelihood of false negative results, thereby reflecting the effectiveness of the imaging modality relative to the IHC reference standard. Sensitivity was presented overall for all IHC-positive results and separately using stricter IHC cut-off values categorized as: \> 50: Overall positive versus negative expression; \> 100: Moderate to high expression and \> 200: High expression only.

  Day 1

• Specificity of [18F]FAPI-74 PET Imaging to Detect Absence of FAP-Expressing Cells, Using IHC as Truth Standard

  Specificity was defined as the proportion of participants without IHC-confirmed FAP-expressing cells who had a negative \[18F\]FAPI-74 PET result for the primary lesion. Specificity was calculated by comparing positive and negative \[18F\]FAPI-74 PET findings with the corresponding IHC results, using a single readable PET image matched to its reference IHC assessment. Specificity was calculated as D / (B + D), where B represents false-positive findings and D represents true-negative findings. PET results were compared with the corresponding IHC reference assessment using a single readable PET image per participant. Specificity was evaluated overall using IHC negativity defined as \> 50: Overall positive versus negative expression; \> 100: Moderate to high expression and \> 200: High expression only.

  Day 1

Secondary Outcomes (3)

• PPV of [18F]FAPI-74 PET Images to Detect Cancer Cells Using Histopathology as Truth Standard

  Day 1

• Sensitivity of [18F]FAPI-74 PET Imaging to Detect Cancers Cells, Using Histopathology as Truth Standard

  Day 1

• Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

  From study intervention administration (Day 1) to 72 hours post-injection

Study Arms (1)

[18F]FAPI-74 PET/CT

EXPERIMENTAL

Patients receive \[18F\]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later

Drug: [18F]FAPI-74 PET/CT

Interventions

[18F]FAPI-74 PET/CT DRUG

\[18F\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastrointestinal cancers.

[18F]FAPI-74 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
• Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
• No treatment received between tissue sample taken and \[18F\]FAPI-74 PET
• Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
• Age ≥ 18 years
• Completed informed consent as determined per the IRB of record

You may not qualify if:

• Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
• Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
• Need for emergent surgery that would be delayed by participation
• Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
• Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
• Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
• Patients receiving any other investigational agent within the past 28 days
• Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[18F\]FAPI-74 injection
• Known hypersensitivity to any excipients used in \[18F\]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
• Renal or liver function impairment\* \*Defined by liver impairments as AST\>3x the upper limit of normal, ALT\>3x the upper limit of normal, or bilirubin\>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of \>1.5x the upper limit of normal utilizing the Cockcroft Gault formula

Sponsors & Collaborators

• SOFIE: lead

Study Sites (6)

University of California Los Angeles (UCLA) Health

Los Angeles, California, 90095, United States

Location

Massachusetts general hospital

Boston, Massachusetts, 02114, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Cholangiocarcinoma; Stomach Neoplasms; Colorectal Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Neoplasms; Liver Diseases

Results Point of Contact

• Title: Bridget Adams, Director of Clinical Operations
• Organization: Sofie Biosciences, Inc

bridget.adams@sofie.com

+319 421-8448

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: April 28, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 1, 2026
• Results First Posted: October 1, 2026

Record last verified: 2026-09

Locations

US (6)