Patients with metastatic solid tumours, where clinical data has shown a rationale for ICI therapy.
Conditions
Brief summary
Evaluation of 89Zr-Df-crefmirlimab biodistribution in cancer patients on the PET images at baseline and during anti-PD-1 antibody therapy., Assessment of the pharmacokinetic properties of 89Zr-Df-crefmirlimab in patients prior to and during treatment with an anti-PD-1 antibody, Baseline and on-treatment 89Zr-Df-crefmirlimab uptake in tumours (expressed as standardized uptake value), CD8 expression in tumour biopsy samples, as determined by IHC., Tumour volumetry, mpMRI parameters and MRI based texture metrics at baseline and during anti-PD-1 antibody therapy.
Detailed description
Local and systemic signs and symptoms of infusion reactions, incidence of adverse events per NCI CTCAE v5.0 criteria, changes in laboratory test results, vital signs and 12-lead electrocardiogram (ECG) findings., mpMRI parameters such as Ktrans derived from DCE-MRI; f, D derived from IVIM-DWI and DDKI and K derived from DK-MRI with tumour and immune cell CD8 expression as well as T cell infiltration., 89Zr-Df-crefmirlimab PET measurements (expressed as standardized uptake values) with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of 89Zr-Df-crefmirlimab biodistribution in cancer patients on the PET images at baseline and during anti-PD-1 antibody therapy., Assessment of the pharmacokinetic properties of 89Zr-Df-crefmirlimab in patients prior to and during treatment with an anti-PD-1 antibody, Baseline and on-treatment 89Zr-Df-crefmirlimab uptake in tumours (expressed as standardized uptake value), CD8 expression in tumour biopsy samples, as determined by IHC., Tumour volumetry, mpMRI parameters and MRI based texture metrics at baseline and during anti-PD-1 antibody therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and systemic signs and symptoms of infusion reactions, incidence of adverse events per NCI CTCAE v5.0 criteria, changes in laboratory test results, vital signs and 12-lead electrocardiogram (ECG) findings., mpMRI parameters such as Ktrans derived from DCE-MRI; f, D derived from IVIM-DWI and DDKI and K derived from DK-MRI with tumour and immune cell CD8 expression as well as T cell infiltration., 89Zr-Df-crefmirlimab PET measurements (expressed as standardized uptake values) with radiologic response to treatment, according to (i)RECIST v1.1 criteria. | — |
Countries
Netherlands
Outcome results
None listed