We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 13, 2021
First Posted Date  ICMJE January 25, 2021
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE April 12, 2022
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging
Official Title  ICMJE A Phase I Study Evaluating the Safety and Imaging Characteristics of 18F-LY3546117 Injection in Subjects Who Are Undergoing Treatment With Immune Checkpoint Inhibitors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neoplasms
  • Neoplasms Malignant
Intervention  ICMJE
  • Drug: 18F-LY3546117 Injection
    370 megabecquerel (MBq) intravenous injection
  • Procedure: PET Scan
    positron emission tomography (PET) scan
Study Arms  ICMJE
  • Experimental: 18F-LY3546117 Scan Cohort 1
    18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy
    Interventions:
    • Drug: 18F-LY3546117 Injection
    • Procedure: PET Scan
  • Experimental: 18F-LY3546117 Scan Cohort 2
    18F-LY3546117 PET scan at time of immune checkpoint therapy response
    Interventions:
    • Drug: 18F-LY3546117 Injection
    • Procedure: PET Scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04721756
Other Study ID Numbers  ICMJE 18F-LY3546117-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Avid Radiopharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avid Radiopharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Avid Medical Director Avid Radiopharmaceuticals, Inc.
PRS Account Avid Radiopharmaceuticals
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP