A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors

Phase 2

Recruiting

• Conditions: Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit

• Registration Number: NCT04260256
• Lead Sponsor: CellSight Technologies, Inc.

Brief Summary

In this study, patients with advanced solid tumors will undergo \[18F\]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.

Detailed Description

Up to 40 patients will be recruited to participate in this study. Two (2) target lesions per patient will be selected for radiomics and biopsy. Both lesions will be assessed for \[18F\]F AraG uptake before and after CkIT. Only one lesion will be biopsied twice (once before and once after CkIT treatment close to the time of imaging), and the other lesion will not be manipulated and used as a control.

There will be a pre therapy scan \[18F\]F AraG which will be administered anytime within a 14 day period prior to the initial Day 1 CkIT administration. There will also be a post therapy scan which will be performed within 3 to 6 weeks after the initial CkIT dose. The timing of the second \[18F\]F AraG scans may be altered based on preliminary results from the initial patient scan results, and could be obtained during the first 2 weeks after initiation of therapy.

The investigators will compare the \[18F\]F AraG activity (based on development of tumoral volumes of interest (VOIs) pre and post CkIT in both lesions.

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2022-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Solid tumor with planned CkIT
• Must be >18 years old
• Signed Informed Consent Form
• Patient must have two qualifying lesions

Exclusion Criteria

• Patient is pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies	24 Months	Pre and post CkIT biopsies of the same tumor lesion will be performed an analyze T-cell tumor infiltration, this will be correlated to \[18F\]F-AraG PET signal.

Secondary Outcome Measures

Name	Time	Method
1. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months) using iRECIST criteria	24 Months
2. Correlate change in [18F]F AraG signal in lung and GI tract with the occurrence of Grade 3 or 4 immune related adverse events.	24 Months

Trial Locations

Locations (2)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Stanford University; 🇺🇸 Stanford, California, United States