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[18F]-AraG -PET imaging to evaluate immunological response to checkpoint inhibitor therapy (CKI) in patients with advanced solid tumors

Award Number: R01CA240638
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Contact PD/PI: Kummar, Shivaani PROJECT SUMMARY/ABSTRACT Immunotherapy, specifically checkpoint inhibitor (CKI) therapy, has resulted in dramatic and sustained tumor responses in patients with a variety of advanced cancers, such as melanoma, non-small cell lung cancer, head and neck cancer and others. However, only a subset of patients with advanced solid tumors derive clinical benefit, and of those a substantial portion progress over time. The ability to better select patients likely to respond to CKI therapy would optimize delivery; and reduce the number of patients exposed to agents not likely to work on their disease. There are multiple ongoing efforts focusing on blood or tissue based biomarkers; and number of immune cells, especially T cells, in the tumor lesions has correlated with tumor response to CKI treatment. However, it remains difficult and risky to biopsy solid tumor lesions repeatedly in a given patient. Since imaging can be safely performed at multiple time points, and multiple disease sites can be assessed simultaneously, it presents an attractive strategy for patient selection. [18F]F-AraG, a 18F-labeled analog of arabinofuranosylguanine (AraG), has been shown to be selectively taken up by T cells in laboratory models and in initial human studies. We hypothesize that [18F]F-AraG signal will increase in patients who develop T-cell immune responses in tumor following CKI therapy, and this will correlate with subsequent clinical benefit. In aim 1, we will correlate changes in [18F]F-AraG signal to number of T cells in tumor biopsies obtained pre and post-treatment with CKI. In our second aim, we will correlate the change in [18F]F-AraG signal following treatment to observed clinical benefit, defined as either tumor stabilization or shrinkage. In the third aim, correlate change in [18F]-AraG signal in lung and GI tract with the subsequent occurrence of higher grade immune related adverse events. Data generated from the proposed study will inform development of a novel imaging biomarker of response to immunotherapies, optimizing patient selection and outcome. In addition, our ability to predict which patients will go on to develop more severe toxicities will inform institution of therapies earlier to mitigate these side effects, as well as personalize management of adverse events.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $1 )
2024	2024	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	000	3	2/14/2024	NON-COMPETING CONTINUATION	$1
2024	2024	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	001	3	4/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	000	2	9/18/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	000	2	4/5/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $451,542 )
2021	2021	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	001	2	3/31/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$451,542
2021	2021	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	Cancer Detection and Diagnosis Research	003	2	5/4/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$384,593
2021	2020	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Detection and Diagnosis Research	002	1	5/4/2021	NEW	-$384,593
2021	2020	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Detection and Diagnosis Research	000	1	3/31/2021	NEW	$0
														Subtotal = $451,542

Issue Date FY: 2020 ( Subtotal = $423,444 )
2020	2020	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Detection and Diagnosis Research	000	1	2/27/2020	NEW	$423,444
														Subtotal = $423,444

Grand Total All Awards = $874,987

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[18F]-AraG -PET imaging to evaluate immunological response to checkpoint inhibitor therapy (CKI) in patients with advanced solid tumors

Award Number: R01CA240638

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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