Overview

A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab

Status:
Not yet recruiting

Trial end date:
2026-02-10

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to determine the safety and tolerability of 89Zr-DFO-REGN5054 alone and in combination with cemiplimab. The secondary objectives include: For Part A: - To characterize the radioactivity pharmacokinetic (PK) profile of 89Zr-DFO-REGN5054 - To establish an adequate mass dose and activity dose of 89Zr-DFO-REGN5054 and optimal post-infusion time for imaging For Parts A and B: - To evaluate the association of CD8 expression in tissue biopsies [via immunohistochemistry (IHC)] with tumor 89Zr˗DFO˗REGN5054 uptake in vivo [via positron emission tomography (PET)] and ex vivo (via autoradiography) - To evaluate the uptake of 89Zr˗DFO˗REGN5054 in tumors, normal CD8-expressing tissues, and blood

Phase:

Phase 1

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Treatments:

Cemiplimab