NOT-CA-22-027 - Notice of Intent to Publish a Funding Opportunity Announcement for Systematic Testing of Radionuclides in Preclinical Experiments (STRIPE) (R21 Clinical Trial Not Allowed)

National Cancer Institute (NCI)

This Notice is to inform the research community that the National Cancer Institute intends to issue a Funding Opportunity Announcement (FOA) to solicit applications for the Systematic Testing of Radionuclides in Preclinical Experiments (STRIPE) program. The STRIPE program seeks to support pre-clinical research projects utilizing state-of-the-art cancer biology methods and model systems that study how radiopharmaceutical therapy (RPT) agents affect the biology of normal tissue, tumor cells and the tumor microenvironment. Ideally, proposed aims will be designed to test hypotheses on how RPT dynamically impacts cancer biology processes, which can serve as the pre-clinical basis for developing new targeting strategies and approaches. Studies supported by this PAR will ultimately inform the rationale and design of new RPT-based clinical trials.

This Notice is being provided to allow potential applicants sufficient time to develop a responsive proposal. The STRIPE program FOAs will utilize the R01 activity code for pre-clinical research. Applications seeking support for clinical trials will not be allowed. The FOAs are expected to be published in February 2022 with an expected application due date in June 2022.
 

While the physical parameters of radionuclide particle emissions are well established, knowledge of their biological effects beyond DNA lesioning events is scant. Moreover, few studies are conducted to examine the effects of the specific types of radiation used in RPT in combination with other therapeutic agents. Mechanistic studies using current “-omic” tools and relevant pre-clinical model systems have strong potential to elucidate new targets (e.g., pathways, phenotypes, microenvironment) for both radiopharmaceutical agents used alone and in combination with conventional targeted therapies. A goal of the STRIPE program is to strengthen and expand pre-clinical cancer biology perspectives in RPT research toward the goal of developing new strategies that leverage the full range of RPT’s unique properties in treatment of cancers. Examples of pre-clinical research supported through this PAR include, but not limited to the following activities:
• Identification of new targets and/or targeting strategies for RPT;
• Selective targeting of cancer specific pathway, organelle, or process;
• Development of synthetic lethality approaches;
• Advancing PD biomarkers or microdosimetry based on theranostic capabilities;
• Testing of novel RPT molecular targeted therapy combinations;
• Understanding polypharmacy mechanisms for RPT-drug combinations;
• Measurement of RPT effects to optimize treatment regimens for recalcitrant resistant or metastatic disease;
• Examination of RPT effects on organs at risk to improve therapeutic index;
• Mechanisms of adaptation to RPT that underlie emergence of resistance, treatment response (success or failure).

The intent of this FOA is to support pre-clinical experiments. Responsive proposals may include human subjects research; however, human clinical trials will not be supported through this PAR.
A project that focuses entirely on developing computational or in silico modeling of RPT response(s) is not responsive to this PAR. Multi-PI applications will be encouraged to maximize the potential of team science efforts and combine capabilities that might be necessary to fulfill the need for specialized multidisciplinary research at the intersection between RPT drug development and cancer biology research.