RFA-CA-19-007: The Experimental Therapeutics Clinical Trials Network (UM1 Clinical Trial Required)
Internal Deadline: February 22, 2019, noon PT
LOI: 30 days prior to the application due date
External Deadline: May 22,2019, by 5:00 PM local time of applicant organization.
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 10
Anticipated Amount: NCI intends to commit $19,450,000 in FY 2020 to fund up to approximately 10 awards. Application budget requests are limited to $1,250,000 (direct costs) per year.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Individual(s) designated as Program Director(s)/Principal Investigator(s) (PDs/PIs) on the applications for ETCTN awards are expected to be nationally- and internationally-recognized leaders in cancer-related clinical trials of novel therapeutic agents, translational research, and related clinical areas relevant to such studies. These individuals should also be recognized leaders in the relevant areas of science and have documented administrative leadership experience.
In addition, an individual designated as a contact PD/PI must have primary affiliation with the application submitting institution (i.e., the LAO). If additional PDs/PIs are designated, they may be affiliated either with the LAO or participating AO.
If the ETCTN contact PD/PI is not a practicing physician, a physician(s) must be designated to be responsible for overseeing the clinical trial(s) and patient management. This physician must have primary affiliation with the submitting institution (i.e., the LAO).
The purpose of this Funding Opportunity Announcement (FOA) issued by The National Cancer Institute (NCI) is to continue support for the Experimental Therapeutics Clinical Trials Network (ETCTN) for the efficient and comprehensive conduct of early phase clinical trials of NCI Investigational New Drug (IND) agents. The ETCTN is designed to assure the availability of investigators and programs with expertise in early drug development and translational research for this purpose. This FOA solicits UM1 cooperative agreement applications from appropriate multidisciplinary groups that can assemble an appropriate infrastructure and conduct phase 0, phase 1, phase 2, pilot and other experimental therapeutics clinical trials involving agents for which the NCI’s Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP) received IND status. The FOA is open to any qualified applicant regardless of whether they have been previously associated with the ETCTN.
The research objective of the ETCTN is for the early-stage clinical development of novel cancer treatments that include NCI-IND agents based on sound preclinical findings, and that are consistent with national priorities for developmental therapeutics clinical cancer research. To meet this objective, all ETCTN awardees jointly will be expected to:
- Use a coordinated and collaborative integrated team science approach in the drug development process.
- Acquire high quality human specimens for ETCTN correlative laboratory studies.
- Integrate scientific rigor into biomarker development and clinical trials.
- Provide efficient and timely activation and conduct of clinical trials that meet regulatory requirements and Good Clinical Practice (GCP) standards and principles.
- Promote collaborations with cancer biology experts to investigate critical pathways and processes in the treatment of oncology patients with investigational drugs.
- Provide clinical study leadership opportunities for early career clinical investigators.
- Commit to enrollment of racial/ethnic and rural populations to decrease cancer disparities.
ETCTN clinical studies conducted during the renewal of the program as described in this FOA are expected to continue to determine the safety of NCI IND agent drug combinations, find early signals of clinical activity of these agents in targeted populations, and perform in-depth analysis of biomarkers of response and resistance. ETCTN investigators will continue to be expected to design and lead ETCTN trials in collaboration with NCI and pharmaceutical partners.
The overarching purpose of the ETCTN is to develop novel NCI-IND anticancer agents and to molecularly characterize tumors to find appropriate biomarkers to select patients most likely to respond to specific agents. In addition to determining safety and tolerability, the clinical trials conducted in the network seek early signals of clinical activity of these agents in targeted populations and perform in-depth analysis of biomarkers of response and resistance. The ETCTN promotes biomarker-rich clinical evaluation of single agent and novel agent combinations and is committed to the conduct of trials in underserved populations and patients with rare tumors.
The ETCTN is assisted by the Investigational Drug Branch (IDB) of NCI’s Cancer Therapy Evaluation Program (CTEP). The ETCTN UM1 awards provide the infrastructure (including clinical sites) and expertise in conducting early phase trials using NCI-IND agents. CTEP currently holds approximately 100 INDs for investigational oncology agents which involve 60 pharmaceutical/biotechnology collaborators. CTEP efforts involve combining novel agents from different pharmaceutical companies which is often difficult to accomplish without NCI support. Agents under evaluation include small molecules, immune-oncology agents, antibodies, antibody-drug conjugates, vaccines, radionuclides, targeted toxins, oligonucleotides, and oncolytic viruses. NCI accepts new agents into its portfolio continuously through the NCI’s Experimental Therapeutics (NExT) program and negotiates Collaborative Research and Development Agreements (CRADAs) with pharmaceutical companies and academic investigators to develop and evaluate these agents within the ETCTN. The ETCTN is currently conducting approximately 79 trials, of which 53 trials are those testing novel drug combinations.
Visit our Institutionally Limited Submission webpage for updates and other announcements.