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Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

NCT04721756 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-25

No results posted yet for this study

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

DRUG

18F-LY3546117 Injection

370 megabecquerel (MBq) intravenous injection

PROCEDURE

PET Scan

positron emission tomography (PET) scan

Sponsors & Collaborators

  • Avid Radiopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Avid Medical Director · Avid Radiopharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Australia

Study Locations

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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 NCT04721756 on ClinicalTrials.gov