A Phase II, Open Label, Multi-center Study of 89Zr-DF-Crefmirlimab for CD8 Positron Emission Tomography in Patients With Locally Advanced or Metastatic Solid Tumours

NCT06534190 Phase 2 RECRUITING

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.

Details

Lead sponsor	University Medical Center Groningen
Phase	Phase 2
Status	RECRUITING
Enrolment	30
Start date	2025-03-11
Completion	2028-11

Conditions

• Locally Advanced Solid Tumor

Interventions

• 89Zr-Df-crefmirlimab PET scan
• Nivolumab
• Cetrelimab
• zirconium Zr 89 crefmirlimab berdoxam

Primary outcomes

• Whole body distribution of 89Zr-Df-crefmirlimab — 2 years
  Evaluate whole body distribution of 89Zr-Df-crefmirlimab in cancer patients prior to and during treatment with an anti-PD-1 antibody by measuring standardized uptake values (SUV) in tumours, healthy tissues and organs.
• Pharmacokinetics (PK) of 89Zr-Df-crefmirlimab — 2 years
  Description of pharmacokinetics (PK) of 89Zr-Df-crefmirlimab by measuring standardized uptake value (SUV) on PET scans performed in patients prior to and during treatment with an anti-PD-1 antibody.
• Tumour tracer uptake with immune cell CD8 expression — 2 years
  Results of immunohistochemical (IHC) scoring of CD8 expression will be described. These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
• Changes in tumour volumetry, mpMRI parameters and MRI based texture metrics — 2 years
  DCE-MRI sequences will be evaluated and both semi-quantitative and pharmacokinetic quantitative parameters will be derived using a two-compartmental model.

Countries

Netherlands, Spain, United Kingdom