NCT06534190

CD8 PET Imaging in Metastatic Solid Tumours

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
RADIATION	89Zr-Df-crefmirlimab PET scan	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.
DRUG	Nivolumab	Immunotherapy treatment with Nivolumab
DRUG	Cetrelimab	Immunotherapy treatment with cetrelimab
OTHER	zirconium Zr 89 crefmirlimab berdoxam	89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later

Timeline

• Start date: 2025-03-11
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-08-02
• Last updated: 2026-02-09

Locations

4 sites across 3 countries: Netherlands, Spain, United Kingdom