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Advanced Solid TumorPhase 1NCT05259709

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

A Phase 1 study testing 89Zr˗DFO˗REGN5054 and cemiplimab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Regeneron Pharmaceuticals at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
89Zr˗DFO˗REGN5054 and cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteNetherlands
Study dates
7 Feb 2023to 29 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • UMC Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

Official title: A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies 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.

Read more

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)
Being tested
89Zr˗DFO˗REGN5054, cemiplimab
Keywords
Positron Emission Tomography (PET) scan, Immuno-PET
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 89Zr˗DFO˗REGN5054Drug

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

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Administered by IV infusion every 3 weeks (Q3W).

Study groups in NCT05259709
Study groupRoleWhat they receive
Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimabExperimentalPart A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
Receives: Drug: 89Zr˗DFO˗REGN5054; Drug: cemiplimab
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimabExperimentalPart B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
Receives: Drug: 89Zr˗DFO˗REGN5054; Drug: cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Part A

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

  2. Incidence and severity of TEAEs

    Part A and B

    Measured: Up to approximately week 115

Secondary outcomes (9)

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

    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

    Measured: On days 1, 5 and 8

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

    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.

    Measured: On days 1, 5 and 8

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

    Part A

    Measured: On days 1, 5 and 8

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

    Part A

    Measured: Up to day 8

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

    Part A and Part B

    Measured: At the time of imaging, up to day 8

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

    Part A and Part B

    Measured: At the time of imaging, up to day 8

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

    Part A and Part B

    Measured: At Baseline

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

    Part B

    Measured: At Baseline

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

    Part B

    Measured: At Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start7 Feb 2023
  3. Primary completion29 Apr 2027 (estimated)
  4. Study completion29 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259709
Sponsor's protocol ID
R5054-ONC-1843
Other IDs
2019-001604-38, 2024-515351-37-00, 2019
Status last verified
Oct 2026
First submitted
24 Jan 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 89Zr˗DFO˗REGN5054 and cemiplimab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Regeneron Pharmaceuticals at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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