Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2027

Conditions
NSCLC
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.

Trial Locations (2)

72074

Eberhard Karls Universitaet Tuebingen (EKUT), Tübingen

6525 GA

Radboud University Medical Center (Radboudumc), Nijmegen

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

ImaginAb, Inc.

INDUSTRY

collaborator

University Hospital Tuebingen

OTHER

lead

Radboud University Medical Center

OTHER

NCT06218069 - Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor | Biotech Hunter | Biotech Hunter