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89Zr˗DFO˗REGN5054

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Sep 11, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

89Zr˗DFO˗REGN5054 · 1 trial · 2 indications

Phase 1 1
NCT05259709A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With CemiplimabAdvanced Solid Tumor
RECRUITING50 Analytics
PHASE1RECRUITING
A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Advanced Solid Tumor
NCT0525970950
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Study Endpoints

Primary Endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs)
Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054

Part A

Incidence and severity of TEAEs
Up to approximately week 115

Part A and B

Secondary Endpoints

Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data
On days 1, 5 and 8
Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data
On days 1, 5 and 8
Concentration of 89Zr-DFO-REGN5054 in serum
On days 1, 5 and 8
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimabEXPERIMENTALPart B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.

Interventions

NameTypeDescription
89Zr˗DFO˗REGN5054DRUGAdministered by intravenous (IV) infusion during Part A and B.
cemiplimabDRUGAdministered by IV infusion every 3 weeks (Q3W).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Netherlands
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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