Status:
RECRUITING
A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 6 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05259709
Start Date
February 7 2023
End Date
January 6 2027
Last Update
September 11 2025
Active Locations (1)
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1
UMC Groningen
Groningen, Netherlands, 9700 RB