A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
NCT ID: NCT05259709
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2023-02-07
2027-01-06
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part A:
Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
89Zr˗DFO˗REGN5054
Administered by intravenous (IV) infusion during Part A and B.
cemiplimab
Administered by IV infusion every 3 weeks (Q3W).
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part B:
Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
89Zr˗DFO˗REGN5054
Administered by intravenous (IV) infusion during Part A and B.
cemiplimab
Administered by IV infusion every 3 weeks (Q3W).
Interventions
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89Zr˗DFO˗REGN5054
Administered by intravenous (IV) infusion during Part A and B.
cemiplimab
Administered by IV infusion every 3 weeks (Q3W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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UMC Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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2019-001604-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-515351-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
R5054-ONC-1843
Identifier Type: -
Identifier Source: org_study_id
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