Checkpoint Inhibitor Therapy Response Assessment for Cancer

Phase 2

Recruiting

Led By Erik Mittra, M.D.

Research Sponsored by CellSight Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be over 18 years old

Solid tumor with planned CkIT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will assess if a treatment can shrink tumors by looking at how much of a certain tracer is taken up by the tumor before and after treatment.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors who are planning to receive checkpoint inhibitor therapy (CkIT). They must have at least two qualifying lesions and provide signed informed consent. Pregnant or breastfeeding individuals cannot participate.Check my eligibility

What is being tested?

The study is testing the use of a special PET/CT imaging technique using [18F]F AraG to see how well patients with solid tumors respond to CkIT, which is a type of cancer treatment that helps the immune system fight cancer.See study design

What are the potential side effects?

While this trial focuses on imaging techniques rather than direct treatment, side effects may relate to the PET/CT scan procedure itself such as discomfort from lying still during the scan or reactions to tracer injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

My solid tumor is planned for a CkIT test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met