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Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor
Sponsor: Radboud University Medical Center
Summary
This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with \[89Zr\]crefmirlimab berdoxam PET imaging as an imaging biomarker.
Official title: Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (IMPRINT)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-02
Completion Date
2027-03
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
Sasanlimab
6 mL of the study drug will be administered subcutaneous injection in the abdominal fat fold. If SC injections in the abdominal location are not possible, SC injections can be administered in a distributed manner in the thighs. SC injections in the upper extremities (eg, deltoid, upper and lower arm) are not permitted. Any observed abnormality at the injection site (e.g. erythema, induration, ecchymosis, injection site pain, injection site pruritus) will be monitored and judged by the investigator to determine whether a corresponding AE should be reported.
non-ablative radiotherapy
Patients will receive a total dose of 24Gy irradiation to the tumor, fractionated in 3 doses of 8Gy, on three consecutive days and starting on the day of first sasanlimab administration.
[89Zr]Zr-crefmirlimab berdoxam
Prior to sasanlimab injection and prior to surgery, \[89Zr\]Zr-crefmirlimab berdoxam (1.5 mg protein dose labelled with activity dose 37 MBq Zirconium-89) will be administered via an intravenous catheter. After 21-27 hours after injection patient will undergo a whole-body PETscan te detect CD8+ T-cell infiltration.
Locations (2)
Eberhard Karls Universitaet Tuebingen (EKUT)
Tübingen, Germany
Radboud University Medical Center (Radboudumc)
Nijmegen, Gelderland, Netherlands