Opportunity Information: Apply for PAR 25 081
The National Cancer Institute (NCI) funding opportunity PAR-25-081 supports investigator-initiated early phase clinical trials under the NIH R01 grant mechanism, with a specific emphasis on cancer-targeted diagnostic and therapeutic interventions. The core purpose is to fund research projects that actually carry out at least one clinical trial in Phase 0, Phase I, or Phase II, rather than projects limited to preclinical development or trial planning. The work must align with the mission areas associated with NCI's Division of Cancer Treatment and Diagnosis (DCTD) and the Office of HIV and AIDS Malignancy (OHAM), meaning the proposed intervention and trial should be directly relevant to cancer treatment, cancer diagnosis, cancer imaging, radiation-related approaches, complementary and alternative medicine strategies in the cancer context, and/or cancers affecting people with HIV/AIDS.
A key requirement is that the application includes at least one early phase clinical trial that fits the scientific interests of one or more NCI programs, specifically the Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program, and the HIV and AIDS Malignancies Research Programs. Applicants can structure the project as a stand-alone early phase trial or combine the trial with additional research aims, such as correlative biomarker work, imaging validation, pharmacodynamic assessments, mechanism-of-action studies in patients, or other supportive objectives that strengthen interpretation of safety signals, preliminary efficacy, dosing rationale, or diagnostic performance. The overall theme is translation into the clinic: generating human data that can move a promising targeted therapy or diagnostic approach forward.
This opportunity is categorized as a discretionary grant program administered by the National Institutes of Health, with NCI as the sponsoring institute. It uses the R01 funding instrument and is listed under CFDA numbers 93.393, 93.394, 93.395, and 93.399, reflecting NCI research areas that cover broad cancer research and related clinical investigations. The listing indicates an award ceiling of $499,999 (as provided in the source data). The original closing date is January 7, 2027, and the opportunity record shows a creation date of November 12, 2024.
Eligibility is broad and includes many types of domestic U.S. applicants, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special districts), as well as independent school districts and public housing authorities/Indian housing authorities. Tribal entities are explicitly included, both federally recognized Native American tribal governments and tribal organizations that are not federally recognized governments. The opportunity also highlights additional eligible applicant categories, including 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), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and eligible federal agencies. Notably, non-domestic (non-U.S.) entities (foreign organizations) are also listed among other eligible applicants, which can be important for multinational expertise or patient populations, although applicants would still need to ensure the proposed trial operations meet all applicable NIH and regulatory expectations.
In practical terms, this NOFO is aimed at researchers who are ready to test a cancer-focused diagnostic or therapeutic strategy in humans and can justify an early phase clinical trial design, population, endpoints, and operational plan. Competitive projects typically make a clear case for why the intervention is ready for Phase 0/I/II evaluation, how the trial will answer a specific translational question (safety, dose, feasibility, target engagement, diagnostic accuracy, preliminary activity), and how results will inform the next development step. The emphasis on being investigator-initiated means the scientific direction comes primarily from the applicant team, while still fitting within the defined programmatic interests of NCI's relevant treatment, diagnosis, imaging, radiation, complementary approaches, and HIV-associated malignancy portfolios.Apply for PAR 25 081
- 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 2024-11-12.
- Applicants must submit their applications by 2027-01-07.
- Each selected applicant is eligible to receive up to $499,999.00 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: NCI PAR-25-081 (R01) Early Phase Clinical Trials for Cancer-Targeted Diagnostics and Therapeutics
What is PAR-25-081?
PAR-25-081 is a National Cancer Institute (NCI) funding opportunity that supports investigator-initiated early phase clinical trials using the NIH R01 grant mechanism. The opportunity is focused on cancer-targeted diagnostic and therapeutic interventions and is intended to generate human clinical data that can move a promising approach forward.
What is the main purpose of this funding opportunity?
The core purpose is to fund research projects that actually conduct at least one early phase clinical trial in humans (Phase 0, Phase I, or Phase II). Projects that are limited to preclinical development or clinical trial planning only are not the central focus of this opportunity.
Do I have to include a clinical trial in my application?
Yes. A key requirement is that the application includes at least one early phase clinical trial (Phase 0, I, or II) that aligns with the scientific interests of one or more relevant NCI programs.
Which clinical trial phases are supported?
This opportunity supports early phase clinical trials in Phase 0, Phase I, or Phase II.
Can the project include research aims beyond the clinical trial?
Yes. The project can be structured as a stand-alone early phase trial or it can combine the trial with additional aims that strengthen interpretation and translational value. Examples mentioned include correlative biomarker work, imaging validation, pharmacodynamic assessments, and mechanism-of-action studies in patients.
What kinds of interventions are in scope?
The emphasis is on cancer-targeted diagnostic and therapeutic interventions. The proposed intervention and trial should be directly relevant to cancer treatment and/or cancer diagnosis, including related areas such as cancer imaging, radiation-related approaches, complementary and alternative medicine strategies in the cancer context, and cancers affecting people with HIV/AIDS.
Which NCI mission areas and programs does the project need to align with?
The work must align with mission areas associated with NCI's Division of Cancer Treatment and Diagnosis (DCTD) and the Office of HIV and AIDS Malignancy (OHAM). The clinical trial should fit the scientific interests of one or more of the following NCI programs listed in the opportunity: Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program, and the HIV and AIDS Malignancies Research Programs.
Is this opportunity limited to treatment trials, or are diagnostic trials eligible too?
Diagnostic-focused work is explicitly within scope. The opportunity highlights cancer-targeted diagnostic interventions and references programmatic interests that include cancer imaging and cancer diagnosis. Therapeutic trials are also within scope, including radiation-related approaches and complementary and alternative medicine strategies in a cancer context.
What types of outcomes or questions are these early phase trials expected to address?
The opportunity emphasizes translation into the clinic and generating human data. Examples of trial questions mentioned include safety, dose, feasibility, target engagement, diagnostic accuracy, preliminary activity/efficacy signals, and generating data that support dosing rationale or diagnostic performance.
What grant mechanism is used?
The funding instrument is the NIH R01 research project grant.
Who is the sponsoring agency?
This is a discretionary grant program administered by the National Institutes of Health (NIH), with the National Cancer Institute (NCI) as the sponsoring institute.
What is the listed award ceiling for this opportunity?
The opportunity listing indicates an award ceiling of $499,999 (as provided in the source data).
What CFDA numbers are associated with this opportunity?
The opportunity is listed under CFDA numbers 93.393, 93.394, 93.395, and 93.399.
When is the closing date?
The original closing date shown for this opportunity is January 7, 2027.
When was the opportunity record created?
The opportunity record shows a creation date of November 12, 2024.
Who is eligible to apply?
Eligibility is broad and includes many types of applicants, including public and private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special districts). Independent school districts and public housing authorities/Indian housing authorities are also included.
Are tribal entities eligible?
Yes. Tribal entities are explicitly included, including federally recognized Native American tribal governments and tribal organizations that are not federally recognized governments.
Are minority-serving institutions or faith-based/community-based organizations eligible?
Yes. The opportunity highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, TCCUs, and faith-based or community-based organizations.
Are U.S. territories or regional organizations eligible?
Yes. U.S. territories or possessions and regional organizations are listed among eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included among the listed eligible applicant categories.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-domestic (non-U.S.) entities (foreign organizations) are listed among other eligible applicants. Applicants would still need to ensure that proposed trial operations meet applicable NIH and regulatory expectations.
What does "investigator-initiated" mean in this context?
"Investigator-initiated" means the scientific direction is primarily set by the applicant team. At the same time, the proposed work must fit within the defined programmatic interests described for NCI's relevant treatment, diagnosis, imaging, radiation, complementary approaches, and HIV-associated malignancy portfolios.
What makes a project a good fit for this opportunity based on the description?
Based on the information provided, a strong fit is a team that is ready to test a cancer-focused diagnostic or therapeutic strategy in humans, can justify an early phase clinical trial design (including population, endpoints, and operations), and can clearly explain why the intervention is ready for Phase 0/I/II evaluation and how the resulting human data will inform the next development step.
Can the trial be the only aim, or must there be multiple aims?
Either is allowed. The application can propose a stand-alone early phase trial or include additional supportive aims (such as biomarkers or pharmacodynamics) alongside the clinical trial.
Is trial planning alone sufficient for this NOFO?
No. The stated emphasis is on projects that carry out at least one early phase clinical trial, rather than projects limited to preclinical development or trial planning only.
Does the opportunity mention specific scientific areas within cancer research that are especially relevant?
Yes. The opportunity specifically calls out cancer treatment, cancer diagnosis, cancer imaging, radiation-related approaches, complementary and alternative medicine strategies in the cancer context, and cancers affecting people with HIV/AIDS.
Does this opportunity focus on generating preclinical data?
The emphasis is on translation into the clinic and generating human data through Phase 0/I/II trials. Preclinical work is not presented as the central purpose; the opportunity is designed for projects that conduct an early phase clinical trial.
Browse more opportunities from the same category: Education, Health
Next opportunity: AIDS Education and Training Center National Clinician Consultation Center
Previous opportunity: Advancing Community Health Activity (ACHA)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 25 081
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 25 081) also looked into and applied for these:
| Funding Opportunity |
|---|
| Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) Apply for PAR 25 167 Funding Number: PAR 25 167 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional) Apply for PAR 25 170 Funding Number: PAR 25 170 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Tobacco, Alcohol, and Cannabis Policy Research for Health Equity (R21 Clinical Trial Optional) Apply for PAR 25 241 Funding Number: PAR 25 241 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Tobacco, Alcohol, and Cannabis Policy Research for Health Equity (R01 Clinical Trial Optional) Apply for PAR 25 240 Funding Number: PAR 25 240 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Developing novel theory and methods for understanding the genetic architecture of complex human traits (R01 Clinical Trial Not Allowed) Apply for PAR 25 255 Funding Number: PAR 25 255 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Developing novel theory and methods for understanding the genetic architecture of complex human traits (R21 Clinical Trial Not Allowed) Apply for PAR 25 256 Funding Number: PAR 25 256 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required) Apply for PAR 25 072 Funding Number: PAR 25 072 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Impacts of climate change across the cancer control continuum (R01 Clinical Trial Optional) Apply for PAR 25 094 Funding Number: PAR 25 094 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Mentored Research Scientist Development Award to Promote Diversity (K01 Independent Clinical Trial Not Allowed) Apply for PAR 24 316 Funding Number: PAR 24 316 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NIDA Research Education Program for Clinical Researchers and Clinicians (R25 Clinical Trial Not Allowed) Apply for PAR 25 204 Funding Number: PAR 25 204 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| Impacts of climate change across the cancer control continuum (R21 Clinical Trial Optional) Apply for PAR 25 152 Funding Number: PAR 25 152 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Basic Research in Cancer Health Disparities (R21 Clinical Trial Not Allowed) Apply for PAR 25 244 Funding Number: PAR 25 244 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed) Apply for PAR 25 243 Funding Number: PAR 25 243 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Investigator Initiated Innovation in Computational Genomics and Data Science (R21 Clinical Trial Not Allowed) Apply for PAR 25 229 Funding Number: PAR 25 229 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Investigator Initiated Innovation in Computational Genomics and Data Science (R01 Clinical Trial Not Allowed) Apply for PAR 25 228 Funding Number: PAR 25 228 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed) Apply for PAR 25 096 Funding Number: PAR 25 096 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed) Apply for PAR 25 095 Funding Number: PAR 25 095 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| NCMRR Early Career Research Award (R03 Clinical Trial Optional) Apply for PAR 25 124 Funding Number: PAR 25 124 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R21 Clinical Trial Not Allowed) Apply for PAR 25 070 Funding Number: PAR 25 070 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R01 Clinical Trial Optional) Apply for PAR 25 069 Funding Number: PAR 25 069 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 25 081", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.