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New scan could reveal how well your immune system fights cancer

NCT ID NCT05259709

Diagnosis Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests an experimental imaging agent (89Zr-DFO-REGN5054) that may help visualize immune cells called CD8+ T cells in tumors. About 50 people with advanced solid cancers will receive the imaging agent along with the immunotherapy drug cemiplimab. The main goal is to check safety and see if the scan can show how the immune system responds to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
89Zr-DFO-REGN5054 (imaging agent) and cemiplimab (cancer drug)
What this could lead to
If successful, this imaging method could help doctors see how well the immune system is attacking tumors, guiding better use of immunotherapy.
What could go wrong
This is an early Phase 1 study with only 50 participants, so the imaging agent may not work as hoped or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UMC Groningen

    RECRUITING

    Groningen, 9700 RB, Netherlands

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