Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

Early Phase 1

• Conditions: Neoplasms; Neoplasms Malignant
• Interventions: Drug: 18F-LY3546117 Injection; Procedure: PET Scan

• Registration Number: NCT04721756
• Lead Sponsor: Avid Radiopharmaceuticals

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 available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Status Verified: 2022-04
• Study Start: 2022-04-12
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
18F-LY3546117 Scan Cohort 1	18F-LY3546117 Injection	18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy
18F-LY3546117 Scan Cohort 1	PET Scan	18F-LY3546117 PET scan at baseline and between 14-42 days after initiation of immune checkpoint therapy
18F-LY3546117 Scan Cohort 2	18F-LY3546117 Injection	18F-LY3546117 PET scan at time of immune checkpoint therapy response
18F-LY3546117 Scan Cohort 2	PET Scan	18F-LY3546117 PET scan at time of immune checkpoint therapy response

Primary Outcome Measures

Name	Time	Method
Cohort 1: Uptake of 18F-LY3546117 in tumor foci and other organs of the body	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	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)

Trial Locations

Locations (1)

Olivia Newton-John Cancer Institute and Austin Health; 🇦🇺 Heidelberg, Victoria, Australia