Single Source: Pediatric Early Phase Clinical Trials Network (PEP-CTN; UM1 Clinical Trial Required) | RFA CA 24 007

Opportunity Information: Apply for RFA CA 24 007

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is offering a cooperative agreement opportunity titled "Single Source: Pediatric Early Phase Clinical Trials Network (PEP-CTN; UM1 Clinical Trial Required)" under funding opportunity number RFA-CA-24-007 (CFDA 93.395). The purpose of this program is to strengthen and expand NCI's capacity to run early phase pediatric cancer clinical trials, with a strong emphasis on moving high-priority new therapies into testing for children as quickly and safely as possible. A central goal is to support "first-in-children" studies, which are viewed as a critical step in the broader national clinical research pipeline for pediatric oncology, especially when promising agents are emerging from adult oncology development or preclinical pediatric work and need timely evaluation in children.

The core scope of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is the design and execution of pediatric Phase 1 clinical trials, and these studies will often include Phase 2 expansion cohorts. In practical terms, the network is expected to determine safe dosing, characterize side effects and toxicities, and understand how novel agents behave in children, while also allowing efficient transition into early signals of activity through Phase 2 expansion when appropriate. The NOFO highlights that housing Phase 2 components within the PEP-CTN structure is intended to be operationally efficient and to enable intensive toxicity monitoring at the point when a drug is being evaluated in children for the first time, which is typically the highest-risk period for unknown pediatric tolerability.

Beyond combined Phase 1/Phase 2 designs, the network is also expected to conduct Phase 2 studies once Phase 1 testing results are available for an agent, meaning PEP-CTN remains involved beyond dose-finding when an agent warrants additional early efficacy and safety characterization. In addition, the NOFO explicitly includes pilot studies of novel regimens, aimed at determining tolerability so that combinations or new approaches can be advanced to more definitive, larger-scale Phase 3 testing. This positions the network as an early-development engine: it helps select and shape which therapies or regimens are ready to move forward, and it generates the dosing, safety, feasibility, and preliminary activity data that later trials rely on.

This opportunity uses a cooperative agreement mechanism (UM1), which generally indicates substantial programmatic involvement from NIH/NCI compared with a standard research project grant. The title also specifies "Clinical Trial Required," signaling that awardees are expected not only to plan but to actively conduct clinical trials as part of the funded work. The opportunity falls within the Health and Education activity categories, reflecting both the clinical research mission and the training/knowledge-generation aspects inherent in running complex multi-site pediatric trials.

Eligibility is limited. The listed eligible applicants include public and state-controlled institutions of higher education, consistent with the academic medical center and university-based infrastructure typically needed for pediatric oncology trials. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may, under NIH rules and with appropriate justification and oversight, include certain foreign activities or collaborations that meet NIH's definition and requirements for a foreign component, even though the applicant organization itself must be U.S.-based.

Key administrative details included in the source information are that the NOFO was created on August 25, 2023, with an original closing date of November 15, 2023. The award ceiling and expected number of awards are not specified in the provided data excerpt, which suggests applicants would need to consult the full NOFO text for budget limits, project period, and program scale. Overall, the opportunity is designed to ensure that promising cancer therapies reach children earlier, that early pediatric safety and dosing questions are answered efficiently, and that the field has a coordinated network capable of moving from first-in-children evaluation through early expansion and pilot regimen testing in a way that supports subsequent definitive trials.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Single Source: Pediatric Early Phase Clinical Trials Network (PEP-CTN; UM1 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
• This funding opportunity was created on 2023-08-25.
• Applicants must submit their applications by 2023-11-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA CA 24 007

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