Early Phase Clinical Research Support

早期临床研究支持描述我们开发了一个专门的癌症实验治疗计划(CETI)，该计划提供资源和基础设施，以促进共济会癌症中心(MCC)研究计划中最有前途的翻译想法的发展。CETI的基本目标是增加新的研究人员发起的早期临床试验的登记人数。这与CCSG的这一部分完全一致，旨在使用MCC资源来管理和实施早期临床研究支持，包括CCSG、慈善事业(如共济会的捐赠)和我们临床合作伙伴的投资。目标是优先考虑从基础研究实验室到翻译并进入临床的开发管道中任何有希望的新疗法。为了指导早期临床试验的优先顺序，我们成立了CETI第一阶段团队。该团队由科学家、内科和外科肿瘤学家以及在MCC副主任领导下的研究人员组成。我们已经建立了支持指南，其中包括以下标准：1)促进可持续努力(为未来播种)的能力，2)与MCC优先事项的一致性，3)在12个月内至少招收6名患者的能力(所有相互冲突的试验都需要与特定地点的团队一起制定管理计划)，以及4)科学界的新颖性。只有由研究人员发起的研究才会被考虑为这种支持，首先是在人类中，并且是第一阶段。我们已经建立了这一进程，并将其应用于过去在《议定书》《特定研究支助》项下的支助，以获得势头。CETI的第一阶段团队已经确定了6项试验的优先顺序，我们预计这些试验将使用早期CCSG支持机制进行支持。所有这些试验都没有启动，预计所有试验都将在下一个供资周期内遵循支助准则。这些新试验包括：1)EGF4KDEL双特异性配体导向毒素治疗晚期EGFR*实体肿瘤(由肿瘤微环境计划成员Dan Vallera开发的翻译发现)，2)针对WHO 11级和III级脑膜瘤患者的疫苗免疫治疗的第一阶段研究(由免疫学成员John Ohifest开发)，3)间皮瘤溶瘤麻疹病毒疗法的第一阶段试验(由癌症遗传机制成员Robert Kratzke开发)，4)CD16/CD33双特异性免疫引擎以增强自然杀伤细胞活性(由植物生物学和免疫学成员Jeffrey Miller和肿瘤微环境成员Daniel Vallera开发)，5)利托那韦联合二甲双胍治疗女性复发/转移性乳腺癌(由细胞信号转导计划成员David Potter开发的翻译发现)，和6)PF-05019702(孕激素受体激动剂-027)治疗腔性乳腺癌患者的评估(由细胞信号转导计划负责人Carol Lange开发)。

Early Phase Clinical Research Support Description We have developed a dedicated Cancer Experimental Therapeutics Initiative (CETI) that provides resources and infrastructure to facilitate development ofthe most promising translational ideas from Masonic Cancer Center (MCC) Research Programs. The fundamental goal of CETI is to increase enrollment onto novel investigator-initiated early-phase clinical trials. This is in complete alignment with this CCSG section and is intended to manage and implement Early Phase Clinical Research Support using MCC resources, including the CCSG, philanthropy (such as the Masons' gift), and investments from our clinical partners. The goal is to prioritize promising new therapies anywhere in the developmental pipeline from the basic research laboratory to translation and into the clinic. To guide early-phase clinical trial priorities, we have formed a Phase 1 CETI Team. This team consists of scientists, medical and surgical oncologists, and research staff under the direction of the MCC Deputy Director. We have established guidelines for support that include the following criteria: 1) ability to foster a sustainable effort (to seed the future), 2) consistency with MCC priorities, 3) ability to accrue at least 6 patients in 12 months (all conflicting trials need management plans with site-specific teams), and 4) novelty within the scientific community. Only studies that are investigator initiated, first in human, and phase 1 will be considered for this support. We have established this process and have applied it to past support under Protocol Specific Research Support to gain momentum. The Phase I team within CETI has prioritized 6 trials that we anticipate supporting using the Early Phase CCSG support mechanism. None of these trials has been initiated and all are expected to follow the guidelines for support during the next funding cycle. These novel trials include: 1) EGF4KDEL Bispecific Ligand-Directed Toxin in the Treatment of Advanced EGFR* Solid Tumors (Translational discovery developed by Tumor Microenvironment Program member Dan Vallera), 2) Phase I Study of Vaccine Immunotherapy in Patients with WHO Grade 11 and III Meningiomas (Translational discovery developed by Immunology Program member John Ohifest), 3) Phase I Trial of Oncolytic Measles Virotherapy in Mesothelioma (Translational Discovery developed by Genetic Mechanisms of Cancer Program member Robert Kratzke), 4) CD16/CD33 Bispecific Immune Engagers to Enhance Natural Killer Cell Activity (Translational discovery developed by Transplant Biology and Therapy and Immunology member Jeffrey Miller and Tumor Microenvironment member Daniel Vallera), 5) The Ml Derivative of Ritonavir Combined with Metformin in Women with Recurrent/Metastatic Breast Cancer (Translational discovery developed by Cell Signaling Program member David Potter), and 6) Assessment of PF-05019702 (Progesterone Receptor Agonist-027) for Treatment of Patients with Luminal Breast Cancer (Translational discovery developed by Cell Signaling Program Leader Carol Lange).