As two NCI-designated comprehensive cancer centers that were collaborative as prior UOl sites, the University of Wisconsin Carbone Cancer Center (UWCCC) and Rutgers Cancer Institute of New Jersey (CINJ) have proven leadership, a robust infrastructure, and a strong record of conducting clinical trials collaboratively. UWCCC and CINJ have, therefore, formed the Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics (WIN-Alliance) with a mission to develop and evaluate innovative early phase experimental therapeutic clinical trials in a multi-disciplinary and multi-institutiona model. Scientific strengths include a translational emphasis with biomarker development; pharmacogenomic assessment; genomic assessment and treatment; clinical and tissue imaging; and systems biology. Organizationally, we have formed working groups that leverage scientific expertise and infrastructural strengths from center shared resources to prioritize ET-CTN efforts. Specific niches unique to the WIN-Alliance include strong PK/PD efforts at UWCCC already adding value to CTEP/U01 clinical trials; complementary imaging strengths at UWCCC and CINJ; genomic analysis using the Rutgers University Cell and DNA Repository (RUCDR); and CINJ's relationship with the Institute for Advanced Study's Simons Center for Systems Biology. Over the past five-years UWCCC and CINJ accrued over 4,000 patients on all therapeutic trials, developed 67 center science driven proposals to NCI-CTEP, and accrued a mean of the targeted 100 patients/yr to the UOl supported studies. The specific aims are to: 1) develop and perform early clinical trials with new ET-CTN sponsored anti-cancer agents; 2) leverage and synergize with center programmatic areas of research and cores to translate scientific discoveries from the laboratory into clinical trials; 3) develop integrated and integralgenomic, pharmacogenomics, pharmacokinetic, and pharmacodynamic biomarkers; 4) develop integral and integrated novel approaches to clinical and tissue imaging; and, 5) train and develop young investigators in translational research. RELEVANCE: This application will merge two strong prior Phase I (UOl) sites to create the Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics (WIN-Alliance). This group, as a synergistic, multidisciplinary and multi-institutional model, will develop and evaluate innovative, early phase experimental therapeutic clinical trials to improve clinical outcomes.