The National Cancer Institute’s Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis program provides R01 funding for clinical research evaluating new or improved approaches to cancer diagnosis and treatment.
Applications must include at least one NIH-defined clinical trial and may involve Phase 0, Phase I, or Phase II studies. Research may address anticancer drugs and biologics, immunotherapies, imaging technologies, radiation therapy, surgical interventions, biomarkers, diagnostics, devices, or complementary and integrative approaches relevant to NCI research priorities. (Grants.gov)
Eligibility Criteria:
- Public and private institutions of higher education are eligible.
- Eligible state, local, tribal, and federal government organizations may apply.
- Foreign/non-U.S. organizations are eligible.
- Organizations may submit more than one application provided the proposals are scientifically distinct.
- New, renewal, resubmission, and revision applications are permitted.
- Cost sharing or matching funds are not required.
Funding Details:
- Maximum budget: $499,999 in direct costs per year.
- Maximum project period: 5 years.
- Therefore, a project funded at the maximum annual amount for five years could receive up to $2,499,995 in direct costs.
- The number of awards is not predetermined and depends on NIH appropriations and the number of meritorious applications.
- Grant Amount: Up to $2,499,995 in direct costs over 5 years
Deadline for the remaining 2026 submission cycle:
- New applications: October 5, 2026, at 5:00 PM local time of the applicant organization
- Renewal, resubmission, and revision applications: November 5, 2026, at 5:00 PM local time
- NOFO expiration: January 8, 2027
Further Information:
- Official program page: Review the opportunity on Simpler.Grants.gov for the official listing, eligibility information, funding details, and application documents.
- Full NCI funding announcement: Read PAR-25-081 on the NIH Grants & Funding website for complete program requirements, research scope, review criteria, and submission instructions.
- Application submission: Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace.
- Scientific contacts: NCI provides separate program contacts for therapeutic, imaging, radiation research, biomarker, complementary medicine, and HIV/AIDS malignancy studies. Applicants are encouraged to contact the relevant NCI scientific officer approximately 12 weeks before submission; contact information is available in Section VII of the official NOFO.
- Funding Opportunity Number: PAR-25-081. Applicants should use this number when searching NIH/Grants.gov systems and preparing their application.