drugset / Trial / NCT04721756

Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

NCT04721756 ↗

Phase 0 Unknown 30 enrolled Avid Radiopharmaceuticals
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

Immuno-Oncology (IO) therapies have revolutionized cancer therapy and are becoming the standard of care for many cancers. Monitoring how well IO therapies work against cancer is difficult due to the complexity of the immune system and the fact that an immune response may initially increase, rather than decrease, the size of a tumor. An early response marker would be beneficial to determine which patients should remain on a given treatment or combination of treatments, and which patients should seek other treatment options. 18F-LY3546117 is a radiolabeled tracer that binds to a specific protein (Granzyme B) that is found in the human immune system and is thought to trigger programmed cell death. It is thought that imaging Granzyme B activity in tumors and elsewhere in the body using a Positron Emission Tomography (PET) scan will allow doctors to monitor the progress of IO therapy.

Timeline

Start
2022-04-12
Primary completion
2024-04
Completion
2024-04

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-LY3546117 Diagnostic / imaging agent 370 mbq Intravenous

Indications