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

Last updated: February 11, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

cemiplimab

89Zr˗DFO˗REGN5054

Clinical Study ID

NCT05259709
R5054-ONC-1843
2024-515351-37-00
2019-001604-38
2022-500868-36-00
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy

  • Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

  • Adequate organ and bone marrow function as defined in the protocol

  • Willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for Part B)

Exclusion

Key Exclusion Criteria:

  • Currently receiving another cancer treatment or inadequate time since last therapy,as defined in the protocol

  • Has not yet recovered from acute toxicities from prior therapy; exceptions definedin the protocol

  • Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1) pathway

  • Currently receiving or has received chimeric antigen receptor (CAR-T) cell therapy

  • Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cordcompression

  • Known history of or any evidence of interstitial lung disease, active, noninfectiouspneumonitis (past 5 years) or active tuberculosis

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: cemiplimab
Phase: 1
Study Start date:
February 07, 2023
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • UMC Groningen

    Groningen, 9700 RB
    Netherlands

    Active - Recruiting

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