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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04721756




Registration number
NCT04721756
Ethics application status
Date submitted
13/01/2021
Date registered
25/01/2021
Date last updated
25/04/2022

Titles & IDs
Public title
Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging
Scientific 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
Secondary ID [1] 0 0
18F-LY3546117-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Neoplasms Malignant 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18F-LY3546117 Injection
Treatment: Surgery - PET Scan

Experimental: 18F-LY3546117 Scan Cohort 1 - 18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy

Experimental: 18F-LY3546117 Scan Cohort 2 - 18F-LY3546117 PET scan at time of immune checkpoint therapy response


Treatment: Drugs: 18F-LY3546117 Injection
370 megabecquerel (MBq) intravenous injection

Treatment: Surgery: PET Scan
positron emission tomography (PET) scan
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body
Timepoint [1] 0 0
Day 14 up to Day 42 of immune checkpoint inhibitor therapy
Primary outcome [2] 0 0
Cohort 2: Uptake of 18F-LY3546117 in tumor foci and other organs of the body
Timepoint [2] 0 0
At immune checkpoint inhibitor treatment response (Day 42 up to 6 months post-treatment)

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Olivia Newton-John Cancer Institute and Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avid Radiopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04721756
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Avid Medical Director
Address 0 0
Avid Radiopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Avid Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
215-298-0700
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04721756