CD8 PET Imaging in Metastatic Solid Tumours

Sponsor
University Medical Center Groningen
Study ID
NCT06534190
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • 89Zr-Df-crefmirlimab PET scan — RADIATION
    89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment. After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab.
  • Nivolumab — DRUG
    Immunotherapy treatment with Nivolumab
  • Cetrelimab — DRUG
    Immunotherapy treatment with cetrelimab
  • zirconium Zr 89 crefmirlimab berdoxam — OTHER
    89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later

Study Details

This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.

Key Dates

Start date
Mar 11, 2025
Status verified
Mar 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD8 PET imaging
    89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment. After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab.

Primary Outcome Measure

Whole body distribution of 89Zr-Df-crefmirlimab [ Time Frame: 2 years ]

Central Contacts

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