National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required) | PAR 21 033

Opportunity Information: Apply for PAR 21 033

The National Institutes of Health, through the National Cancer Institute (NCI), is offering the grant opportunity titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)" under Funding Opportunity Number PAR-21-033. This is a discretionary grant program using the R01 research project grant mechanism, and it is specifically designed to support investigator-initiated early phase clinical trials that align with the mission and priorities of NCI's Division of Cancer Treatment and Diagnosis (DCTD). The central aim is to move promising cancer-focused diagnostics and therapies into human testing in a structured, hypothesis-driven way, while generating the kinds of safety, feasibility, and early efficacy signals that can justify later-stage development.

Projects proposed under this FOA must include research that meets the NIH definition of a clinical trial, meaning the application needs to describe a prospective study in which human participants are assigned to an intervention to evaluate effects on health-related biomedical or behavioral outcomes. The FOA is focused on early phase studies only: Phase 0 (often exploratory, including first-in-human microdosing or pharmacodynamic assessments), Phase I (primarily assessing safety, dosing, and tolerability), and Phase II (typically expanding to examine preliminary efficacy and further characterize safety, sometimes with biomarker-driven or patient-selection strategies). The emphasis is on cancer-targeted diagnostic and therapeutic interventions, so proposals are expected to be clearly tied to cancer treatment and/or cancer diagnosis and to be directly relevant to DCTD priorities. Applicants are encouraged to review the DCTD website (https://dctd.cancer.gov/) to understand NCI's current program goals, research strategies, and priority areas, since the strongest applications usually demonstrate a clear line of sight between the proposed trial and DCTD's broader translational and clinical objectives.

A key limitation of the opportunity is that Phase III clinical trials are explicitly out of scope. Applications proposing Phase III trials in any cancer research area are not sought and will not be supported through this FOA. In practical terms, the FOA is meant to fund the earlier decision-making stages of clinical development, where the main deliverables are credible human data on safety, dosing, target engagement or mechanism, feasibility of delivery, and early signals of clinical activity or diagnostic performance, rather than definitive comparisons of outcomes at scale.

Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic landscape. Eligible applicants include state, county, city or 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; Native American tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that early phase cancer trials can be led by many different kinds of institutions, including academic medical centers, research institutes, consortia, community-based clinical networks, and global partners, provided they can meet NIH expectations for trial conduct, oversight, and reporting.

Administratively, the opportunity is categorized under Education and Health funding activity areas and is associated with CFDA numbers 93.393, 93.394, 93.395, and 93.399. The source information lists an original closing date of 2024-01-07 and a creation date of 2020-11-12. While the award ceiling and expected number of awards are not specified in the provided data, applicants should generally expect R01 budgets and timelines to be justified by the scope and complexity of the proposed clinical trial, including participant accrual, clinical site operations, investigational product or diagnostic development needs, data management, monitoring, regulatory compliance, and required safety oversight.

Overall, PAR-21-033 is aimed at supporting well-designed, investigator-driven Phase 0 to Phase II cancer clinical trials that can efficiently answer critical early development questions for novel cancer therapies and diagnostics, while staying tightly aligned with NCI DCTD priorities and NIH clinical trial requirements, and explicitly avoiding late-stage Phase III trial activity.

• 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 2020-11-12.
• Applicants must submit their applications by 2024-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 21 033

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