Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05259709

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UMC Groningen

Groningen, 9700 RB, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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 defined in 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 cord compression
  • Known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Treatment and study plan

89Zr˗DFO˗REGN5054

Drug

Administered by intravenous (IV) infusion during Part A and B.

cemiplimab

Drug

Administered by IV infusion every 3 weeks (Q3W).

Other names: REGN2810, Libtayo

Primary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054

    Part A

  2. Incidence and severity of TEAEs

    Time frame: Up to approximately week 115

    Part A and B

Secondary outcomes

  1. Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data

    Time frame: On days 1, 5 and 8

    After injection of 37 megabecquerel (MBq) of 89Zr-DFO-REGN5054, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 8 days and corrected for attenuation by low-dose computed tomography (CT) scans using PET/CT. The radiation effective dose per organ/tissue will be calculated for each organ using Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM). The unit of effective dose per organ/tissue will be millisievert per Minimum Base Quantity (MBq) for each participant's organ/tissue. The final values for each organ will be averaged across participants for each mass dose

  2. Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data

    Time frame: On days 1, 5 and 8

    After injection of 37 MBq of 89Zr-DFO-REGN5054, a series of whole-body PET images will be obtained over a period of up to 8 days and corrected for attenuation by low-dose CT scans using PET/CT. The radiation effective dose for the whole body will be calculated using OLINDA/EXM software. The unit of effective dose will be millisievert per MBq for the whole body for each participant. The final values will be averaged across participants for each mass dose.

  3. Concentration of 89Zr-DFO-REGN5054 in serum

    Time frame: On days 1, 5 and 8

    Part A

  4. Serum imaging agent activity concentration of area under the curve (AUC0-7)

    Time frame: Up to day 8

    Part A

  5. 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors

    Time frame: At the time of imaging, up to day 8

    Part A and Part B

  6. Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios

    Time frame: At the time of imaging, up to day 8

    Part A and Part B

  7. Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues

    Time frame: At Baseline

    Part A and Part B

  8. Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues

    Time frame: At Baseline

    Part B

  9. Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues

    Time frame: At Baseline

    Part B

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2022
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.