National Cancer Institute Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

The National Cancer Institute (NCI) invites applications for the R01 Research Project Grant, "Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis." This opportunity supports investigator-initiated early-phase clinical trials (Phase 0, I, and II) targeting novel diagnostic and therapeutic cancer interventions. Proposals must address the research missions of the NCI's Division of Cancer Treatment and Diagnosis (DCTD) and/or the Office of HIV and AIDS Malignancies (OHAM). Eligible clinical trials include evaluations of cancer therapies, diagnostic tools, imaging agents, and integrative medicine approaches. Phase III trials are excluded. The program seeks to advance evidence-based practices and fill unmet needs in cancer treatment and diagnosis. Examples of appropriate projects include trials of new anticancer drugs, biologics, or imaging technologies, as well as biomarker-driven or integrative medicine studies. Research must align with priorities of programs such as the Cancer Therapy Evaluation Program, Cancer Imaging Program, and others under DCTD and OHAM. Applications may propose single-site or multi-site trials, mechanistic or feasibility studies, and may include non-trial research aims if at least one clinical trial is conducted within the project period. Eligible applicants include higher education institutions, nonprofits, for-profits, local governments, tribal organizations, and foreign entities. Project budgets are capped at $499,999 in direct costs per year, with a maximum duration of five years. All proposed research must meet the NIH definition of a clinical trial. Prior engagement with NCI program staff is recommended to ensure alignment with priorities and facilitate application preparation. Applications are reviewed on scientific and technical merit, with specific evaluation of the trial's significance, innovation, design, and feasibility. Trials must address feasibility metrics, recruitment strategies, and clear endpoints, ensuring adherence to Good Clinical Practice and NIH safety monitoring policies. Timelines must outline key milestones, including regulatory approvals and enrollment benchmarks. Submission deadlines follow standard NIH cycles, with the next due dates being February 5, June 5, and October 5 annually through January 2027. Applications must be submitted electronically through ASSIST or Grants.gov. Letters of intent, while not mandatory, are encouraged to facilitate workload planning and review. This funding opportunity provides a platform for early-phase cancer research, fostering innovation and collaboration to address critical gaps in cancer care. Further details, including application requirements and program contacts, are available on the NIH funding website.