Actively Recruiting
A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Led by Regeneron Pharmaceuticals · Updated on 2025-09-11
50
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with advanced or metastatic solid tumors potentially responsive to PD-1 immunotherapy
- Measurable disease based on RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined by the study
- Willing and able to attend clinic visits and complete study procedures including required tumor biopsy in Part B
You will not qualify if you...
- Currently receiving other cancer treatments or insufficient time since last therapy
- Not recovered from acute side effects of prior therapy as defined by the study
- Previous treatment with PD-1 or PD-L1 pathway blockers
- Currently receiving or previously received CAR-T cell therapy
- Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
- History or evidence of interstitial lung disease, active noninfectious pneumonitis within past 5 years, or active tuberculosis
- Other exclusion criteria as defined in the protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
UMC Groningen
Groningen, Netherlands, 9700 RB
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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