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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Neoplasms Malignant
• Intervention / Treatment: Drug: 18F-LY3546117 Injection; Procedure: PET Scan

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Avid Clinical Operations; Phone Number: 215-298-0700; Email: clinicaloperations@avidrp.com

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia
      • Recruiting
      • Olivia Newton-John Cancer Institute and Austin Health
      • Contact: Tina Chen; Phone Number: +613 94965748; Email: Tina.CHEN@austin.org.au
      • Principal Investigator: Prof. Andrew Scott, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (Cohort 1):

• At least one imageable tumor greater than or equal to 15 mm in the longest diameter
• Confirmed diagnosis of cancer with a high likelihood of response to immuno-oncology therapy (melanoma or non-small cell lung cancer, or other malignancies with sponsor approval) and planned mono- or combination therapy with immuno-oncology therapy
• Life expectancy of greater than 6 months

Inclusion Criteria (Cohort 2):

• At least one imageable tumor greater than or equal to 15 mm in the longest diameter or a tumor assessable by PET in the opinion of the radiologist
• Received treatment with an immune checkpoint inhibitor with evidence of response
• Life expectancy of greater than 6 months

Exclusion Criteria:

• Subjects who plan to receive chemotherapy or radiation therapy during study participation
• Prior history of failed immune checkpoint inhibitor therapy
• Subjects who require steroid or other immunosuppressive medications within 2 weeks of the PET scan.
• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration.
• Females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 18F-LY3546117 Scan Cohort 1; 18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy	Drug: 18F-LY3546117 Injection; 370 megabecquerel (MBq) intravenous injection; Procedure: PET Scan; positron emission tomography (PET) scan
EXPERIMENTAL: 18F-LY3546117 Scan Cohort 2; 18F-LY3546117 PET scan at time of immune checkpoint therapy response	Drug: 18F-LY3546117 Injection; 370 megabecquerel (MBq) intravenous injection; Procedure: PET Scan; positron emission tomography (PET) scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body	Visual uptake in the tumor as assessed by sponsor expert reader (Yes/No)	Day 14 up to Day 42 of immune checkpoint inhibitor therapy
Cohort 2: Uptake of 18F-LY3546117 in tumor foci and other organs of the body	Visual uptake in the tumor as assessed by sponsor expert reader (Yes/No)	At immune checkpoint inhibitor treatment response (Day 42 up to 6 months post-treatment)

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2022
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (ACTUAL): January 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cancer Imaging
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 18F-LY3546117-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No