NCT04721756

Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

A Phase I Study Evaluating the Safety and Imaging Characteristics of 18F-LY3546117 Injection in Subjects Who Are Undergoing Treatment With Immune Checkpoint Inhibitors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Avid Radiopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	18F-LY3546117 Injection	370 megabecquerel (MBq) intravenous injection
PROCEDURE	PET Scan	positron emission tomography (PET) scan

Timeline

• Start date: 2022-04-12
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2021-01-25
• Last updated: 2022-04-25

Locations

1 site across 1 country: Australia