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Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor

NCT06218069 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

RADIATION

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.

DRUG

[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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • ImaginAb, Inc.

    collaborator INDUSTRY

  • University Hospital Tuebingen

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Michel M van den Heuvel, Prof.dr. · Radboud University Medical Center (Radboudumc)

  • Dominik Sonanini, Dr. · Eberhard Karls Universitaet Tuebingen (EKUT)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218069 on ClinicalTrials.gov