Actively Recruiting
A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
Led by Regeneron Pharmaceuticals · Updated on 2025-09-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental imaging drug called 89Zr-DFO-REGN5054 along with cemiplimab in patients with advanced or metastatic solid tumors. The study aims to understand the safety and tolerability of the imaging drug and how it behaves in the body, especially how the immune system interacts with tumors treated with cemiplimab. This is a Phase 1 clinical trial led by Regeneron Pharmaceuticals focusing on patients whose tumors may show important immune features through imaging. Participants receive 89Zr-DFO-REGN5054 via intravenous infusion in two parts: Part A involves dose adjustments based on assessments, and Part B uses a defined dose determined from Part A. Cemiplimab is given by intravenous infusion every three weeks. The study combines these treatments to evaluate the imaging agent's distribution and safety alongside standard cemiplimab therapy. During the study, participants undergo PET imaging on days 1, 5, and 8 to assess how the imaging drug is taken up by tumors and normal tissues. Blood samples are collected to measure drug levels and immune response. Researchers monitor side effects up to week 115 and evaluate treatment-emergent adverse events shortly after infusion. Tumor biopsies and other assessments help understand the imaging signals and immune markers. Participants are followed closely throughout to assess safety and drug behavior.
CONDITIONS
Brief 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 aged 18 years or older
- Have advanced or metastatic solid tumors that may respond to anti-PD-1 immunotherapy
- Have measurable disease according to RECIST 1.1 criteria
- Have an ECOG performance status of 0 or 1
- Have 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
You will not qualify if you...
- Currently receiving another cancer treatment or have not waited enough time since last therapy as defined in the protocol
- Have not recovered from acute toxicities of prior therapy, except as allowed by the protocol
- Prior treatment with PD-1 or PD-L1 blockers
- Current or past treatment with CAR-T cell therapy
- Have symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
- Known history or evidence of interstitial lung disease, active noninfectious pneumonitis within past 5 years, or active tuberculosis
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to approximately 115 weeks
Participants receive intravenous infusions of 89Zr-DFO-REGN5054 and cemiplimab every 3 weeks as part of the study treatment.
Infusions every 3 weeks with imaging and blood sample collections on days 1, 5, and 8
Trial Site Locations
Total: 1 location
1
UMC Groningen
Groningen, Netherlands, 9700 RB
Actively Recruiting
Research Team
C
Clinical Trials Administrator
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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