Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

NCT04721756 | Unknown Early Phase 1

• 1 other identifier: 18F-LY3546117-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer Imaging

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

18F-LY3546117 Scan Cohort 1

EXPERIMENTAL

18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy

Drug: 18F-LY3546117 Injection; Procedure: PET Scan

18F-LY3546117 Scan Cohort 2

EXPERIMENTAL

18F-LY3546117 PET scan at time of immune checkpoint therapy response

Drug: 18F-LY3546117 Injection; Procedure: PET Scan

Interventions

18F-LY3546117 Injection DRUG

370 megabecquerel (MBq) intravenous injection

18F-LY3546117 Scan Cohort 1; 18F-LY3546117 Scan Cohort 2

PET Scan PROCEDURE

positron emission tomography (PET) scan

18F-LY3546117 Scan Cohort 1; 18F-LY3546117 Scan Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Olivia Newton-John Cancer Institute and Austin Health

Heidelberg, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Avid Medical Director

  Avid Radiopharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Avid Clinical Operations

CONTACT

215-298-0700; clinicaloperations@avidrp.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 25, 2021
• Study Start: April 12, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)