Early Phase Clinical Research Support

我们已经开发了一个专门的癌症实验治疗计划（CETI），提供资源和基础设施，以促进共济会癌症中心（MCC）研究项目中最有前途的转化思想的发展。CETI的基本目标是增加新的研究者发起的早期临床试验的入组人数。这与CCSG部分完全一致，旨在利用MCC资源管理和实施早期临床研究支持，包括CCSG、慈善事业（如梅森的捐赠）和临床合作伙伴的投资。我们的目标是优先考虑从基础研究实验室到转化和临床的发展管道中的任何有前途的新疗法。为了指导早期临床试验的优先顺序，我们已经组建了一个1期CETI团队。该小组由科学家、内科和外科肿瘤学家以及研究人员组成，由MCC副主任领导。我们已经建立了支持指南，包括以下标准：1)促进可持续努力的能力（播种未来），2)与MCC优先事项的一致性，3)在12个月内积累至少6名患者的能力（所有冲突的试验都需要与特定地点的团队进行管理计划），以及4)科学界的新颖性。只有研究者发起的、首先在人体中进行的、第一阶段的研究才会被考虑获得这种支持。我们已经建立了这一流程，并已将其应用于过去在《议定书》特定研究支持下的支持，以获得动力。CETI的第一阶段团队已经确定了6项试验的优先级，我们期望使用早期CCSG支持机制来支持这些试验。这些试验都尚未开始，预计所有试验都将在下一个供资周期遵循指导方针获得支助。这些新颖的试验包括：1) EGF4KDEL双特异性配体导向毒素治疗晚期EGFR*实体瘤（肿瘤微环境项目成员Dan Vallera的转化发现），2)WHO 11级和III级脑膜瘤患者的疫苗免疫治疗I期研究（免疫学项目成员John Ohifest的转化发现），3)瘤性麻疹病毒治疗间皮瘤的I期试验（癌症遗传机制项目成员Robert Kratzke的转化发现），4)CD16/CD33双特异性免疫参与物增强自然杀伤细胞活性（移植生物学和治疗与免疫学成员Jeffrey Miller和肿瘤微环境成员Daniel Vallera的转化发现），5)利托那韦Ml衍生物联合二甲双胍治疗复发/转移性乳腺癌（Cell Signaling Program成员David Potter的转化发现），6)评估PF-05019702（孕酮受体激动剂-027）治疗腔内乳腺癌（Cell Signaling Program Leader Carol Lange的转化发现）。

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).