NCT06894745

PET [89Zr]DFO-starPEG in Solid Tumors

Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Robert Flavell, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, pilot study of the novel PET-imaging radiotracer \[89Zr\]DFO-starPEG. The study is designed to obtain preliminary data to support future development of this agent as an imaging surrogate to visualize enhanced permeability and retention (EPR)-mediated tracer uptake before administration of EPR-based nanomedicines.

Detailed description

PRIMARY OBJECTIVES: I. To descriptively report patterns of \[89Zr\]DFO-starPEG uptake on whole-body PET (Cohorts A \& B). II. To determine the radiation dosimetry following \[89Zr\]DFO-starPEG administration (Cohort A). SECONDARY OBJECTIVES: I. To determine the safety of \[89Zr\]DFO-starPEG (Cohorts A \& B). EXPLORATORY OBJECTIVES: I. To study the pharmacokinetics of \[89Zr\]DFO-starPEG and estimate its half-life (Cohort A). OUTLINE: Participants will be assigned to one of 2 cohorts: * COHORT A: Participants will receive multiple scans over time * COHORT B: Participants will receive a scan at a single time point Participants will be followed for adverse events for approximately 1 week after radiotracer administration until the Day 5-9 visit.

Conditions

• Solid Tumor
• Solid Carcinoma
• Soft Tissue Lesion

Interventions

Type	Name	Description
DRUG	89-zr-dfo-star polyethylene glycol (StarPEG)	Given intravenously (IV)
PROCEDURE	Whole Body Positron Emission Tomography (PET)	Imaging procedure
PROCEDURE	Specimen Collection	Urine and blood specimens will be collected for correlative studies

Timeline

• Start date: 2025-06-02
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-03-25
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study