The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies

With the evolution of the Experimental Therapeutics Clinical Trials Network (ETCTN), the Johns Hopkins
Translational Science Team (JHTST) expanded in 2016 by bringing 5 (now 6) Affiliate Organizations (AO)
under our Lead Academic Organization (LAO) with the goal to enhance and accelerate our collective
contribution to the drug development efforts of the NCI. We have organized a comprehensive and cohesive
infrastructure that can conduct high-quality clinical trials evaluating novel anticancer agents, in combinations, in
molecularly selected patient populations, or rare tumor sites. Our infrastructure stems from the need to be
clinically efficient, regulatory compliant and scientifically rigorous in our approach as we collaborate as network
members within the ETCTN. Our infrastructure consists of seven experienced NCI-designated Cancer Centers:
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Emory Winship Cancer Institute, Georgetown
Lombardi Comprehensive Cancer Center, Sidney Kimmel Cancer Center at Thomas Jefferson University,
Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, and University of Wisconsin
Carbone Cancer Center. This collection of Centers brings together many unique discovery strengths, diverse
patient volumes, and locations both urban and rural. We will focus on 4 Specific Aims: Aim 1- To lead and
maintain a clinical trial consortium that will support cancer clinical trials from Phase 1 initiation through proof-ofactivity and foster seamless Phase 2 clinical development of NCI CTEP IND agents; Aim 2- To actively
participate and engage disease-focused clinical investigators in the ETCTN by promoting accrual to a range of
ETCTN studies led by other LAO/AO members; Aim 3- To incorporate and implement innovative correlative
and biological laboratory studies in the context of or as eligibility for participation in early phase clinical studies
that enhance our understanding of determinants of toxicity and response that will be used for further definitive
practice-changing clinical trial evaluation; and Aim 4- To train the next generation of investigators in drug
development. With 7 Centers within our Consortium, we anticipate no problem in meeting the grant metrics of
100 accruals per year, submitting enough LOI concepts to have 6 new studies approved each year, functioning
as a network by having Disease-Focused Clinical Investigators champion ETCTN studies at each Site across
disease sites, and to provide opportunities to engage and train early career investigators in drug development.
We anticipate that our contributions within the ETCTN will impact the clinical care of cancer patients.

Grant Number: 5UM1CA186691-09
NIH Institute/Center: NIH
Principal Investigator: Michael Carducci