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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Oregon Health and Science University | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-AraG | Drug | [18F]F AraG injection and PET Scan Two tumor biopsies of single lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies | 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. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carina Mari Aparici, M.D. | Stanford University | Principal Investigator |
| Erik Mittra, M.D. | Oregon Health and Science University | Principal Investigator |
| Shivaani Kummar, M.D. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Oregon Health and Science University |
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| 24 Months |
| Portland |
| Oregon |
| 97239 |
| United States |