National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required) | PAR 24 085

Opportunity Information: Apply for PAR 24 085

The National Cancer Institute funding opportunity PAR 24 085 supports investigator-initiated early phase clinical trials that test new or improved cancer-focused diagnostic or therapeutic interventions. It uses the NIH R01 grant mechanism and explicitly requires at least one clinical trial, with the intent of moving promising ideas into first-in-human, dose-finding, feasibility, and other early efficacy signal-generating studies. The trials must be Phase 0, Phase I, or Phase II and should align with the missions of NCI programs housed within the Division of Cancer Treatment and Diagnosis (DCTD) and the Office of HIV and AIDS Malignancy (OHAM), meaning the work should be directly relevant to NCI priorities in cancer treatment, diagnosis, imaging, radiation, complementary approaches, and cancers affecting people with HIV/AIDS.

A central requirement is that the application include at least one clinical trial that fits within the scientific interests of one or more specified NCI programs: the Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program, and/or the HIV and AIDS Malignancies Research Programs. Applicants can propose a standalone early phase trial or pair the trial with additional research aims, as long as the overall project remains coherent and the clinical trial component is integral to the proposed science. In practical terms, this opportunity is geared toward projects where the investigator is not only studying a concept but actually implementing an early phase clinical study to evaluate a targeted intervention in people, such as a novel therapeutic approach, a diagnostic strategy, an imaging method, or a radiation-related intervention relevant to cancer.

The opportunity is offered by the National Institutes of Health (specifically NCI) as a discretionary grant program in the Education and Health activity category, and it is associated with CFDA numbers 93.393, 93.394, 93.395, and 93.399. The posting lists an original closing date of January 7, 2027, indicating a multi-year window during which applications may be accepted according to the announcement schedule. An award ceiling and expected number of awards are not specified in the provided source text, so applicants typically need to consult the full funding announcement for budget limits, project period expectations, and any institute-specific budget guidance.

Eligibility is broad and includes many common NIH-eligible applicant types: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The announcement also highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth is intended to encourage participation from a wide range of institutions and communities, including those serving populations that are often underrepresented in clinical research.

Overall, PAR 24 085 is designed for investigators who are ready to run an early phase cancer clinical trial and can show strong alignment with NCI DCTD and/or OHAM program interests. It supports the kind of work that bridges promising preclinical or translational findings into real-world clinical testing, with a clear emphasis on implementing the trial itself (not just planning or observational work) and generating actionable early clinical data for cancer treatment and diagnostic development.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.399.
• This funding opportunity was created on 2023-12-15.
• Applicants must submit their applications by 2027-01-07.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 24 085

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