First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

Phase 1

Suspended

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: [89Zr]Zr-DFO-emapalumab

• Registration Number: NCT06439914
• Lead Sponsor: Nerissa T. Viola

Brief Summary

The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.

Detailed Description

Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.

-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Study Start: 2025-06-25
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[89Zr]Zr-DFO-emapalumab	[89Zr]Zr-DFO-emapalumab	Radiotracer \[89Zr\]Zr-DFO-emapalumab injection

Primary Outcome Measures

Name	Time	Method
peak Standard Uptake Value (SUVpeak)	Up to Day 45	Descriptively summarize at baseline and post-immunotherapy treatments.
mean Standard Uptake Value (SUVmean)	Up to Day 45	Descriptively summarize at baseline and post-immunotherapy treatments.
maximum Standard Uptake Value (SUVmax)	Up to Day 45	Descriptively summarize at baseline and post-immunotherapy treatments.

Secondary Outcome Measures

Name	Time	Method
change of SUVpeak	Up to Day 45	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.
change of SUVmean	Up to Day 45	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.
change of SUVmax	Up to Day 45	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.

Trial Locations

Locations (1)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States