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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05259709
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Feb 7, 2023
Status verified
Sep 2025
Primary completion
Jan 6, 2027
Completion
Jan 6, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
    Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
  • Experimental: Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
    Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.

Primary Outcome Measure

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

Central Contacts

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