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).
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