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

StatusRecruiting
PhasePhase 1
Started2023-02-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jan 6, 2027 → May 5, 2027
See other at-risk trials from Regeneron

Amendment history

2026-09-22
Primary completion pushed: 2027-01-06 → 2027-05-05
Completion pushed: 2027-01-06 → 2027-05-05
2025-09-04
Study Identification, Study Status, IPDSharing v9
Primary completion date2025-07-28→2027-01-06
Completion date2025-07-28→2027-01-06
2025-02-11
Study Identification, Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 1 site
2024-12-17
Study Identification, Study Status, Study Description, IPDSharing v7
Re-verified, no change to tracked fields
2024-11-06
Study Identification, Study Status v6
Primary completion date2026-09-17→2025-07-28
Completion date2026-09-17→2025-07-28
Show 5 earlier versions
2023-09-12
Study Status, Study Description, Study Design, Outcome Measures, Eligibility v5
Enrollment target44→50
Eligibility criteria-8 characters
Key Inclusion Criteria: Advanced or metastatic solid tumors that may respond to anti-programmed cell death protein 1 (PD-1) immunotherapy Measurable disease according to Respo [...]
Secondary endpoints9 entries, revised
PlasmaSerum imaging agent activity concentration of area under the curve (AUC0-7)
2023-02-20
Study Status v4
Primary completion date2026-09-08→2026-09-17
Completion date2026-09-08→2026-09-17
Start dateestimated 2023-01-27→confirmed 2023-02-07
2023-02-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05-20→2026-09-08
Completion date2026-05-20→2026-09-08
Start date2022-09-30→2023-01-27
Study sites0→1
2022-09-16
Study Status v2
Primary completion date2026-05-13→2026-05-20
Completion date2026-05-13→2026-05-20
Start date2022-09-09→2022-09-30
2022-08-05
Study Status v1
Primary completion date2026-02-10→2026-05-13
Completion date2026-02-10→2026-05-13
Start date2022-06-23→2022-09-09
2022-02-22
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT05259709
Lead Sponsor Regeneron Pharmaceuticals
Conditions Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 50 participants
Start Date 2023-02-07
Primary Completion 2027-05-05 (estimated)
Study Completion 2027-05-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-21