The new era in drug development represents a paradigm shift in how early phase studies are considered relative to the conventional approach of treating without consideration to underlying tumor genomics, biology and immunology. Translational endpoints, including levels of target expression, engagement, and modulation of downstream effectors are being assessed as early as possible, and increasing emphasis is being placed on early patient selection, utilizing novel biomarker assays, and molecular characterization to identify patients most likely to respond. As these endpoints have become more common, the traditional classification of clinical trials as distinct Phase 1 or Phase 2 studies is often insufficient. Rather, these studies have become blended into an early clinical trial classification, and a wider range of expertise is necessary to conduct them. The ultimate purpose of the NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN) is to define better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and find appropriate biomarkers to select patients most likely to respond to specific agents. While the original ET-CTN UM1 grant had a Phase 1 emphasis, this goal can be better achieved by expanding the scope of activities by merging Phase 2 clinical trials into the Network. This application is a revision to our parent ETCTN UM1 award (1UM1CA186689) with the purpose of describing our capabilities to conduct Phase 2 clinical trials. We have added 2 institutions to our original partnership, and have termed it Vanderbilt-Ingram, Karmanos, TGen Research Institute, Yale - Pacific Coast (University of California-San Diego and University of California-San Francisco) (ViKTriY - PC). As Phase 2 capabilities are added, our team aims to 1) leverage institutional science to develop Phase 2 trials using the CTEP portfolio in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers into novel Phase 2 trials to better understand the effects of novel agents either alone or in combination; 3) and develop fellows and junior faculty who are knowledgeable and proficient in conducting early phase clinical trials across the Phase 1 and 2 spectrum, and help them advance promising trials to Phase 3. The members of this team have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. This ViKTriY-PC team is committed to utilizing their areas of expertise and maximizing their collaborative relationships to conduct cutting- edge Phase 1 and 2 trials within the ET-CTN with the ultimate mission of improving outcomes for patients with cancer.
This revision application adds Phase 2 clinical trial capabilities and 2 new sites to our multidisciplinary group currently conducting Phase 1 experimental cancer therapeutics clinical trials and related correlative translational science studies through the National Cancer Institute Experimental Therapeutics-Clinical Trials Network. Integrating Phase 2 clinical trial infrastructure and expertise to our existing team will allow efficient and comprehensive conduct of early clinical trials, more selective and sophisticated clinical and translational investigational strategies, and seamless advancement of experimental agents through early stages of development.
