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Brief Title: A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors
Official Title: A Phase I Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors
Study ID: NCT03775850
Brief Summary: This study is being conducted to assess the safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, and checkpoint inhibitor relapsed tumors
Detailed Description: This will be a Phase I open-label study which will involve a 2-week monotherapy with EDP1503, following which the patients will be dosed with a combination of EDP1503 and pembrolizumab.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Rogers, Arkansas, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Centre de Recherche du CHUM, Montréal, Quebec, Canada
Jewish General Hospital, Montréal, Quebec, Canada
CHU de Québec - Université Laval, Québec, , Canada
Name: Johanna Bendell, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR