Administrative supplement for Early Drug Development Opportunity Program (EDDOP)

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ABSTRACT This proposal addresses Dartmouth Cancer Center’s (DCC) ability to conduct and participate in cancer early phase clinical trials through the Experimental Therapeutics Clinical Trials Network (ETCTN) of the National Cancer Institute (NCI). It serves as a comprehensive response to the NCI’s P30 Cancer Center Support Grant Administrative Supplement, to NCI-designated Cancer Centers previously participating in Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP), to promote continued collaboration with CTEP’s ETCTN under funding opportunity PA-20-272. DCC’s objectives as an NCI-designated comprehensive cancer center are aligned with ETCTN’s goals to conduct early phase clinical treatment trials across a broad range of cancers and diverse patient populations, with an emphasis on rare diseases. DCC was approved through peer review for the NCI Cancer Center’s Early Phase Clinical Research component of NCI Center Grants. Dartmouth is a Lead Academic Participating Site in the NCI National Clinical Trials Network. We currently are not affiliated with any ETCTN UM1 grantees that are funded to conduct studies of NCI-IND agents with a phase 1, and more recently also with phase 2, emphasis. Our proposal utilizes a pre-existing and functioning cadre of established inter- and multidisciplinary investigators at DCC, The Geisel School of Medicine at Dartmouth (Geisel), Dartmouth Health (DH), and the Thayer School of Engineering at Dartmouth, which share common clinical, basic science and clinical translational research interests in cancer treatment and imaging. We have core laboratories and an infrastructure that supports the conduct of a wide spectrum of correlative science studies typically associated with early phase trials and basic research in cancer biology, immunology, and imaging. As an academic NCI-designated comprehensive cancer center, we are well-positioned to provide scientific leadership in developing and conducting innovative early phase studies of anti-cancer agents held under CTEP’s IND, as well as substantial numbers of patients eligible for accrual to clinical trials conducted across the entire ETCTN.