NCT04621435

Imaging of Solid Tumors Using FAP-2286

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 191 (estimated)
• Sponsor: Thomas Hope · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.

Detailed description

Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer. STUDY AIMS 1. Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286. 2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286. 3. Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286. 2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286. 3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286. 4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286. 5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286. EXPLORATORY OBJECTIVES 1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET). 2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry. 3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function. 4. Determine impact of administered dose of FAP-2286 on image quality. 5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286 A repeat radiolabeled FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Participants will be followed through the day of the last injection of radiolabeled FAP-2286 for evaluation of adverse events.

Conditions

• Solid Tumors, Adult
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Gallium-68 labelled (68Ga-) FAP-2286	The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
PROCEDURE	Positron Emission Tomography (PET) imaging	Participants will be scanned for approximately 30 to 45 minutes
DRUG	Copper-64 labeled (64Cu-) FAP-2286	The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging

Timeline

• Start date: 2020-12-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-11-09
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study