Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required)

The National Cancer Institute, part of the National Institutes of Health within the U.S. Department of Health and Human Services, is offering the Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required) funding opportunity under RFA-CA-27-005. The program uses the U19 Research Program cooperative agreement mechanism and is intended to improve treatment of adult glioblastoma by developing novel effective therapeutic agents that can cross the blood brain barrier and testing them clinically. NCI seeks to establish a highly collaborative Glioblastoma Therapeutics Network composed of multi-institutional U19 teams capable of advancing therapeutic agents from late preclinical development through investigational new drug studies and into pilot or Phase 0/1 clinical studies. Successful early-stage trials are intended to transition to later-stage trials through established NCI clinical trial mechanisms. Each proposed U19 must be a multi-institutional effort involving investigators from two or more institutions, including two institutions capable of accruing patients to GTN clinical trials from non-overlapping catchment areas. Each U19 must contain an Administrative Core with a Network Coordinating Subgroup, exactly two Research Projects, and at least one Shared Resources Core. Research Projects must focus on agents that have completed or are solidly within lead optimization and that are new to GBM treatment. Appropriate candidates include novel agents and agents or combinations approved for other indications that are being repurposed for GBM following relevant preclinical studies. Projects focused on small molecules are preferred, although qualifying biologic agents are also encouraged. Early discovery projects, applications focused on cancers other than adult GBM or Astrocytoma IDH mutant grade 4, projects focused only on GBM biology rather than therapeutic development, and applications lacking GBM-specific preclinical data are non-responsive. NCI intends to commit 4.4 million dollars in total costs in fiscal year 2027 to support approximately three to four awards, subject to appropriations and receipt of a sufficient number of meritorious applications. Application budgets are limited to 700000 dollars in direct costs per year, and costs must reflect the actual needs of the project. The maximum project period is five years. Each U19 must include a restricted Pilot Project Fund of 75000 dollars in direct costs for cross-GTN pilot projects in each of years one through five, with NCI approval required before restricted funds are released. Travel funds must support participation by at least one U19 PD/PI in face-to-face Steering Committee meetings when appropriate. Cost sharing is not required. Pre-award costs are allowable only in accordance with the NIH Grants Policy Statement. Eligible applicants include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, small businesses, other for-profit organizations, state governments, county governments, city or township governments, special district governments, federally recognized and other Indian or Native American tribal governments, eligible federal agencies, U.S. territories or possessions, independent school districts, public or Indian housing authorities, Native American tribal organizations, faith-based or community-based organizations, and regional organizations. Foreign organizations, non-U.S. components of U.S. organizations, and foreign components are not eligible. Applicant organizations must maintain required SAM, Grants.gov, and eRA Commons registrations, and PDs/PIs must have eRA Commons accounts and ORCID registrations. Only one application per institution is permitted, and an investigator may serve as a PI or multi-PI on only one GTN U19 application. Applications must follow the NIH Multi-Project application instructions and the program-specific requirements in the NOFO. Required components include the Overall component, Administrative Core, one to four Shared Resources Cores with at least one required, and exactly two Research Projects. The Overall, Administrative Core, Shared Resources Core, and Research Project components each have a 12-page limit for the applicable research strategy. The application requires detailed scientific aims and strategies, leadership and administrative plans, milestones, clinical development plans, supporting preliminary data, appropriate human subjects and clinical trial information, resource sharing information, letters of support where applicable, and an Overall Data Management and Sharing Plan when scientific data will be generated. Applications must be submitted electronically through NIH ASSIST or an institutional system-to-system solution to Grants.gov and subsequently tracked in eRA Commons. Paper applications are not accepted. Peer review will evaluate scientific and technical merit, including significance, investigators, innovation, approach, and environment, with additional consideration of study timelines, human subjects protections, inclusion policies, vertebrate animals, biohazards, resource sharing, biological and chemical resource authentication, budget, and period of support where applicable. Review of the U19 emphasizes the ability of the integrated program to advance therapeutic candidates from drug development through preclinical testing and into Phase I clinical trials, the rigor and relevance of GBM models and preliminary evidence, leadership of multi-institutional research, and synergy among Projects and Cores. Applications will undergo scientific peer review followed by National Cancer Advisory Board review, and funding decisions will consider scientific and technical merit, availability of funds, and relevance to program priorities. The opportunity was posted August 31, 2026 and opens for applications September 1, 2026. The application deadline for both New and Renewal applications is October 1, 2026 at 5:00 PM local time of the applicant organization, and no late applications will be accepted under this NOFO. Scientific merit review is anticipated in March 2027, Advisory Council review in May 2027, and the earliest anticipated project start date is July 2027. The NOFO expires October 2, 2026. No required pre-application letter of intent, concept paper, or other gating submission is stated. Scientific and research questions may be directed to the NCI GTN Program at GTN-contacts@nih.gov or 240-276-5922. Financial and grants management questions may be directed to the NCI Office of Grants Administration at NCIFinancialContact@nih.gov or 240-276-6291. The source does not state that this opportunity recurs on a regular schedule.

Propose agents that are new to GBM treatment and sufficiently advanced for near-term clinical translation; provide rigorous GBM-specific preclinical evidence and required development-candidate data; demonstrate blood brain barrier penetration and a feasible path through IND-enabling studies to clinical testing; build a genuinely integrated multi-institutional team with complementary laboratory, drug-development, and clinical expertise; ensure two clinical sites have non-overlapping catchment areas and credible accrual capacity; establish measurable milestones and alternatives for delays or failures; demonstrate synergy among Research Projects and Shared Resources Cores; address rigorous study design, data management, quality control, human subjects protections, and feasible clinical trial timelines; follow Multi-Project and program-specific instructions exactly because noncompliant or nonresponsive applications may not be reviewed.