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Children's Oncology Group Pediatric Early Phase Clinical Trial Network

Award Number: UM1CA228823
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/03/2024
PERIOD OF PERFORMANCE END DATE: 07/31/2024

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Children's Oncology Group Pediatric Early Phase Clinical Trial Network - PEP-CTN Project Summary/Abstract: The mission of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to identify and develop effective new agents for children and adolescents with cancer, through rational and efficient clinical and laboratory research. PEP-CTN clinical trials will incorporate correlative genomics, biology, pharmacology, and imaging studies to further the understanding of the disposition and action of new agents introduced into the treatment of children with cancer. Annually, the PEP-CTN will enroll approximately 120 children and adolescents with cancer onto clinical trials of novel anticancer agents at the 21 core-member sites and 21 non-core member sites throughout the US, Canada, and Australia. The network institutions are selected through a peer review process, and serve as a national and international model for new agent development in pediatric oncology. The PEP-CTN leverages the database infrastructure and resources of the parent Children’s Oncology Group (COG) while maintaining its own administrative and operational infrastructure to ensure rapid development, implementation, and reporting of specialized and complex early phase clinical trials. The PEP-CTN has expertise and resources for the conduct of translational biology, pharmacokinetic, and pharmacogenetic studies, and utilizes state-of-the-art informatics systems to facilitate the transfer of response and correlative imaging studies for central review and analyses. The PEP-CTN's primary specific aims are: 1) To safely and efficiently introduce novel anticancer agents into the pediatric setting through the conduct of early phase clinical trials; 2) To expeditiously obtain preliminary efficacy signals through use of phase 2 expansion cohorts and pilot studies in order to inform tumor specific trials that will be conducted across COG sites; 3) To perform genomic analyses, including single gene studies or gene panels, to identify appropriate patients for early phase studies of targeted agents; 4) To identify associations of tumor characteristics with response to new agents using genomic analyses such as whole exome sequencing and RNA sequencing; 5) To incorporate pharmacologic and biologic endpoints, including circulating tumor DNA, other translational laboratory studies, and imaging modalities, into early phase studies, in order to enhance our understanding of the new agents and their effect on tumors Development of targeted therapy for childhood cancer is a high priority as it offers the prospect of more efficacious and less toxic therapeutics. Project Summary/Abstract Page 21


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: 2025 ( Subtotal = $0 )
2025	2024	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	002	5	12/2/2024	SUPPLEMENT FOR EXPANSION	-$185,753
2025	2024	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	001	6	12/2/2024	COMPETING CONTINUATION	$185,753
2025	2024	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	000	6	11/1/2024	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $5,045,791 )
2024	2024	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	002	6	9/11/2024	COMPETING CONTINUATION	$4,445,791
2024	2024	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	001	5	7/16/2024	SUPPLEMENT FOR EXPANSION	$600,000
2024	2022	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	000	5	11/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $5,045,791

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	002	5	3/20/2023	NON-COMPETING CONTINUATION	$0
2023	2021	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	001	4	2/23/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2020	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	3	2/2/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $4,152,554 )
2022	2022	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	004	5	7/29/2022	NON-COMPETING CONTINUATION	$4,152,554
2022	2021	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	003	4	2/23/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$589,221
2022	2021	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 600	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	001	4	1/3/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$2,215,197
2022	2020	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	002	3	2/23/2022	NON-COMPETING CONTINUATION	-$589,221
2022	2020	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	3	1/3/2022	NON-COMPETING CONTINUATION	-$2,215,197
														Subtotal = $4,152,554

Issue Date FY: 2021 ( Subtotal = $4,842,958 )
2021	2021	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 290	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	002	4	9/22/2021	SUPPLEMENT FOR EXPANSION	$638,499
2021	2021	PUBLIC HEALTH INSTITUTE	555 12TH ST STE 290	OAKLAND	CA	94607	ALAMEDA	USA	Cancer Treatment Research	001	4	9/21/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,204,459
2021	2020	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	3	9/21/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,842,958

Issue Date FY: 2020 ( Subtotal = $4,483,491 )
2020	2020	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	3	8/5/2020	NON-COMPETING CONTINUATION	$4,483,491
														Subtotal = $4,483,491

Issue Date FY: 2019 ( Subtotal = $4,639,569 )
2019	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	2	7/25/2019	NON-COMPETING CONTINUATION	$4,639,569
														Subtotal = $4,639,569

Issue Date FY: 2018 ( Subtotal = $4,739,780 )
2018	2018	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Treatment Research	000	1	9/21/2018	NEW	$4,739,780
														Subtotal = $4,739,780

Grand Total All Awards = $27,904,143

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Children's Oncology Group Pediatric Early Phase Clinical Trial Network

Award Number: UM1CA228823

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 05/03/2024

PERIOD OF PERFORMANCE END DATE: 07/31/2024

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