Early Phase Clinical Research Support

早期临床研究支持

• 批准号: 8935217
• 负责人: Douglas Yee
• 金额: $ 23.51万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8935217
• 关键词: Agonist; Agreement; Basic Science; Benchmarking; Biology; Cancer Center; Cancer Center Support Grant; Caring; Cities; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Communities; Conflict (Psychology); Dedications; Development; Enrollment; Epidermal Growth Factor Receptor; FCGR3B gene; Faculty; Fostering; Funding; Future; Genetic; Gifts; Goals; Grant; Guidelines; Health system; Hematology; Human; Immune; Immunology; Immunotherapy; Inpatients; Investments; Laboratories; Ligands; Malignant Neoplasms; Measles; Medical Oncologist; Mentorship; Mesothelioma; Metastatic breast cancer; Metformin; Minnesota; Mission; NCI Center for Cancer Research; Natural Killer Cells; Oncolytic; Paper; Patients; Phase; Philosophy; Physicians; Process; Progesterone Receptors; Protocols documentation; Publishing; Recruitment Activity; Recurrence; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Ritonavir; Scientist; Seeds; Signal Transduction; Site; Solid Neoplasm; Surgical Oncologist; Therapeutic; Time; Toxin; Translations; Transplantation; Twin Multiple Birth; Universities; Vaccines; Virotherapy; Woman; Work; anticancer research; malignant breast neoplasm; member; meningioma; novel; oncology; oncology service; phase 1 study; phase I trial; programs; tumor microenvironment; working group

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).

早期临床研究支持描述我们已经制定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）研究计划中最有前途的转化想法的发展。CETI的基本目标是增加新药物启动的早期临床试验的入组人数。这与CCSG部分完全一致，旨在使用MCC资源管理和实施早期临床研究支持，包括CCSG，慈善事业（如共济会的礼物）和我们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翻译和临床的发展管道中任何有前途的新疗法。为了指导早期临床试验的优先事项，我们成立了1期CETI团队。该小组由科学家、内科和外科肿瘤学家以及MCC副主任指导下的研究人员组成。我们已经制定了支持指南，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优先事项一致，3）能够在12个月内招募至少6名患者（所有冲突的试验都需要与研究中心特定团队一起制定管理计划），以及4）科学界的新奇。只有研究者发起的研究，首次在人体中进行的研究和I期研究将被考虑用于该支持。我们已经建立了这一过程，并已将其应用于过去的支持下，协议特定的研究支持，以获得动力。CETI内的I期团队优先考虑了6项试验，我们预计将使用早期CCSG支持机制支持这些试验。这些审判均未启动，预计在下一个供资周期内，所有审判都将遵循支助准则。这些新试验包括：1）EGF 4KDEL双特异性配体导向的毒素治疗晚期EGFR* 实体瘤（肿瘤微环境项目成员Dan Vallera开发的转化发现），2）WHO 11级和III级脑膜瘤患者疫苗免疫治疗的I期研究（由免疫学项目成员John Ohifest开发的翻译发现），3）间皮瘤中溶瘤性麻疹病毒疗法的I期试验（由癌症遗传机制项目成员Robert Kratzke开发的翻译发现），4）增强自然杀伤细胞活性的CD 16/CD 33双特异性免疫接合剂（由移植生物学和治疗与免疫学成员Jeffrey米勒和肿瘤微环境成员丹尼尔瓦莱拉开发的转化发现），5）利托那韦的Ml衍生物与二甲双胍组合用于患有复发性/转移性乳腺癌的女性（翻译发现由细胞信号计划成员大卫波特开发），和6）PF-05019702的评估（孕激素受体激动剂-027）治疗腔内乳腺癌患者（翻译发现由细胞信号传导项目负责人卡罗尔兰格开发）。