# Children's Oncology Group Pediatric EarlyPhase Clinical Trial Network

> **NIH NIH UM1** · PUBLIC HEALTH INSTITUTE · 2024 · $4,445,791

## Abstract

Project Summary/Abstract
The mission of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to identify and develop effective
new agents and treatment strategies for children and adolescents with cancer, through rational and efficient
clinical and laboratory research. PEP-CTN clinical trials will incorporate correlative genomics, biology,
pharmacology, imaging studies and patient reported outcomes 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 130 children and adolescents with cancer onto clinical trials of novel therapies 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 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 therapeutics
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 and biologic analyses, including single
gene studies or gene panels, and target antigens 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 innovative therapy for childhood cancer is a high priority that offers the prospect of more
efficacious and less toxic therapeutics.
Project Summary/Abstract Page 21

## Key facts

- **NIH application ID:** 10987452
- **Project number:** 2UM1CA228823-06
- **Recipient organization:** PUBLIC HEALTH INSTITUTE
- **Principal Investigator:** Elizabeth Fox
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $4,445,791
- **Award type:** 2
- **Project period:** 2018-09-20 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10987452

## Citation

> US National Institutes of Health, RePORTER application 10987452, Children's Oncology Group Pediatric EarlyPhase Clinical Trial Network (2UM1CA228823-06). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10987452. Licensed CC0.

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