Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05259709

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

Led by Regeneron Pharmaceuticals · Updated on 2025-09-11

50

Participants Needed

1

Research Sites

204 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study is researching an experimental drug called 89Zr-DFO-REGN5054 and cemiplimab. The study is focused on patients with a type of cancer that can be potentially imaged using 89Zr-DFO-REGN5054 and show special tumor features that may be important to the way the immune system fights cancer. The aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89Zr-DFO REGN5054. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with advanced or metastatic solid tumors potentially responsive to PD-1 immunotherapy
  • Measurable disease based on RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Adequate organ and bone marrow function as defined by the study
  • Willing and able to attend clinic visits and complete study procedures including required tumor biopsy in Part B
Not Eligible

You will not qualify if you...

  • Currently receiving other cancer treatments or insufficient time since last therapy
  • Not recovered from acute side effects of prior therapy as defined by the study
  • Previous treatment with PD-1 or PD-L1 pathway blockers
  • Currently receiving or previously received CAR-T cell therapy
  • Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
  • History or evidence of interstitial lung disease, active noninfectious pneumonitis within past 5 years, or active tuberculosis
  • Other exclusion criteria as defined in the protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

UMC Groningen

Groningen, Netherlands, 9700 RB

Actively Recruiting

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Research Team

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Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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