VICKtOrY Early Clinical Trials Consortium

癌症药物开发的新时代代表了如何进行早期研究的范式转变 相对于不考虑潜在肿瘤基因组学、生物学 和免疫学。翻译终点，包括目标表达水平、参与和调节 的下游效应物正在尽早评估，并越来越重视 早期患者选择，利用新的生物标志物测定和分子表征来识别患者， 可能会回应。NCI实验治疗-临床试验网络（ETCTN）的最终目的 是开发新的治疗选择，同时也定义更好的方法来开发新的 抗癌剂，利用的能力，表征肿瘤的分子，并通过也找到适当的 生物标志物，以选择最有可能响应的患者。随着生物标志物驱动的试验成为早期 阶段研究，允许研究反应和抗性的潜在机制， 这些生物标志物的研究有助于新的试验设计， 子集，用较小的招募人群定义更大的患者结局。一个独特的网络 例如ETCTN，由多个科学驱动的站点和调查人员组成， 专业知识，是必须的。ETCTN允许研究者测试相关的床旁检查结果，并通过 综合分析和跨学科团队的发展，采用逆向翻译， 从床边回到长凳上此应用程序是我们以前的ETCTN UM 1奖的重新竞争 （1UM 1CA 186689），展示了我们在过去的资助期内取得的进展以及我们的能力， 进行早期临床试验。我们稍微修改了我们原来的伙伴关系，现在包括 范德比尔特-英格拉姆，加州圣地亚哥大学，卡马诺斯癌症研究所，俄克拉荷马州大学 斯蒂芬森癌症中心（新）和耶鲁癌症中心（维克托）。我们的团队旨在1）利用新的 将科学发现转化为早期试验，使用CTEP药典，用于罕见癌症， 常见癌症和常见癌症的不常见变体; 2）将血清、组织和成像 生物标志物，以更好地了解单独或组合的新药物的作用; 3）培训早期职业生涯 研究者应具备开展早期临床试验的知识和技能， 研究领导机会和指导;以及4）作为我们早期临床试验的组成部分 招聘，不低于10%的服务不足/特殊人群。我们团队的成员有一套独特的 在合作研究和导师制方面， 下一代癌症研究者VICKtOrY致力于利用我们的专业领域，整合 在我们的机构的科学，并最大限度地发挥我们的合作关系，进行尖端的早期 ETCTN内的阶段试验，其最终使命是改善癌症患者的结局。

The new era in cancer drug development represents a paradigm shift in how early phase studies are conducted 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. The ultimate purpose of the NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and by also finding appropriate biomarkers to select patients most likely to respond. As biomarker-driven trials become the cornerstone of early phase investigation, allowing for the study of potential mechanisms of response and resistance, incorporation of these biomarkers is lending itself to novel trial designs which incorporate fewer, and often rarer patient subsets, defining greater patient outcomes with smaller recruited populations. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. The ETCTN allows investigators to test relevant bench-to-bedside findings, and through integrated analysis and the development of interdisciplinary teams, incorporates reverse translation to bring the bedside back to the bench. This application is a re-competition of our previous ETCTN UM1 award (1UM1CA186689), demonstrating both our progress over the past funding period as well as our capabilities to conduct early phase clinical trials. We have slightly amended our original partnerships which now include Vanderbilt-Ingram, University of California San Diego, Karmanos Cancer Institute, University of Oklahoma Stephenson Cancer Center (new) and the Yale Cancer Center (VICKtOrY). Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 10% underserved/special populations. The members of our team have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. VICKtOrY is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.