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Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04721756
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms Neoplasms Malignant Drug: 18F-LY3546117 Injection Procedure: PET Scan Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Study Evaluating the Safety and Imaging Characteristics of 18F-LY3546117 Injection in Subjects Who Are Undergoing Treatment With Immune Checkpoint Inhibitors
Actual Study Start Date : April 12, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body [ Time Frame: Day 14 up to Day 42 of immune checkpoint inhibitor therapy ]
    Visual uptake in the tumor as assessed by sponsor expert reader (Yes/No)

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721756


Contacts
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Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
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Australia, Victoria
Olivia Newton-John Cancer Institute and Austin Health Recruiting
Heidelberg, Victoria, Australia
Contact: Tina Chen    +613 94965748    Tina.CHEN@austin.org.au   
Principal Investigator: Prof. Andrew Scott, MD         
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Avid Medical Director Avid Radiopharmaceuticals, Inc.
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT04721756    
Other Study ID Numbers: 18F-LY3546117-01
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Avid Radiopharmaceuticals:
Cancer Imaging
Additional relevant MeSH terms:
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Neoplasms