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Recruiting NCT05259709

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

Phase I Interventional Advanced Solid Tumor Metastatic Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 89Zr˗DFO˗REGN5054, cemiplimab.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab

Overview

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)

Interventions

  • Drug 89Zr˗DFO˗REGN5054
    Administered by intravenous (IV) infusion during Part A and B.
  • Drug cemiplimab
    Administered by IV infusion every 3 weeks (Q3W).

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [Time frame: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054]
  • Incidence and severity of TEAEs [Time frame: Up to approximately week 115]
Secondary outcome measures (9)
  • Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data [Time frame: On days 1, 5 and 8]
  • Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data [Time frame: On days 1, 5 and 8]
  • Concentration of 89Zr-DFO-REGN5054 in serum [Time frame: On days 1, 5 and 8]
  • Serum imaging agent activity concentration of area under the curve (AUC0-7) [Time frame: Up to day 8]
  • 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors [Time frame: At the time of imaging, up to day 8]
  • Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios [Time frame: At the time of imaging, up to day 8]
  • Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues [Time frame: At Baseline]
  • Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues [Time frame: At Baseline]
  • Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues [Time frame: At Baseline]

Eligibility criteria

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 ≤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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • UMC Groningen — Groningen

Identifiers

NCT: NCT05259709 · R5054-ONC-1843 · 2019-001604-38 · 2024-515351-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗