National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trials Required) | PAR 18 560

Opportunity Information: Apply for PAR 18 560

The National Cancer Institute (NCI) funding opportunity titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trials Required)" (Funding Opportunity Number PAR-18-560) is an NIH discretionary grant solicitation designed to support investigator-led early stage clinical research in cancer. The central goal is to fund projects that actually conduct early phase clinical trials, specifically Phase 0, Phase I, and Phase II studies, focused on improving cancer treatment approaches and/or cancer diagnostic strategies. This FOA sits within the mission space of NCI's Division of Cancer Treatment and Diagnosis (DCTD), meaning proposed trials should align with DCTD program interests and the broader federal research strategy to prevent, detect, and treat cancer more effectively.

A defining feature of this announcement is that applications must include a study that meets the NIH definition of a clinical trial. In practical terms, the project must prospectively assign human participants to an intervention (such as a drug, device, diagnostic approach, imaging strategy, biomarker-guided strategy, behavioral approach, or other clinical intervention) in order to evaluate effects on health-related biomedical or behavioral outcomes. The FOA explicitly calls out NIH's clinical trial policy framework (referencing NOT-OD-15-015) and requires applicants to provide detailed, trial-specific information in the application package as described by the announcement. In other words, this is not a mechanism for preclinical development alone or purely observational human studies; it is intended to move an intervention into first-in-human or early testing, establish safety and dosing, explore feasibility, and generate preliminary evidence of biological or clinical activity consistent with Phase 0 to II objectives.

The announcement strongly encourages applicants to consult the DCTD website (https://dctd.cancer.gov/) before applying so that proposed trials are clearly responsive to DCTD goals, priorities, and strategic approaches. While the summary language does not enumerate specific disease sites or modality constraints, the emphasis on DCTD relevance signals that NCI is looking for trials that fit within its treatment and diagnosis portfolio, and that applicants should be prepared to justify programmatic fit and scientific rationale in a way that matches DCTD's research direction.

From an administrative standpoint, this opportunity uses the NIH R01 grant mechanism and is categorized under the broader funding activity areas of education and health. The associated CFDA (now commonly referenced as Assistance Listing) numbers include 93.393, 93.394, 93.395, and 93.399, reflecting alignment with NCI programs that support cancer cause, diagnosis, treatment, and related research infrastructure. The listed award ceiling is $500,000 (as provided in the source data), indicating the FOA is framed around a defined upper bound per award under the terms reported here. The opportunity was created on 2018-01-05, and the original closing date listed in the provided record is 2020-11-12.

Eligibility is broad and deliberately inclusive across the research ecosystem. Eligible applicants include many types of domestic U.S. public and private entities such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; public housing authorities/Indian housing authorities; small businesses; and for-profit organizations (other than small businesses). The FOA also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations. It further notes eligibility for certain tribal governments and tribal organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. entities (foreign organizations), which is notable because some NIH opportunities restrict foreign participation. Collectively, this eligibility language indicates NCI is aiming to attract a wide range of investigator-initiated trial proposals, including those rooted in diverse communities and institutional settings, as long as the project can meet NIH clinical trial requirements and the scientific and operational standards expected for early phase oncology studies.

Overall, PAR-18-560 is best understood as an NIH/NCI R01 pathway for investigators who are ready to run an early phase cancer clinical trial, with clear expectations that the application will include robust clinical trial design details and demonstrate strong alignment with NCI DCTD priorities in cancer treatment and diagnosis.

• 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 Trials 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 2018-01-05.
• Applicants must submit their applications by 2020-11-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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 18 560

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