A Study of EDP1503 in Patients With Colorectal or Triple Negative Breast Cancer or Cancer That Came Back After Treatment with a Checkpoint Inhibitor

About the Study

Medicines that affect bacteria in the stomach and intestines may assist immunotherapy agents like pembrolizumab (Keytruda) in treating cancer. This study will look at the effect of a drug, EDP1503 on enhancing the anti-cancer response when used with pembrolizumab, in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, or cancers that have recurred after a type of immunotherapy known as an immune checkpoint inhibitor. NOTE: This this study is no longer enrolling patients. 

Type of Study

This is a Phase 1/2 non-randomized, open-label study. Patients will be assigned to one of three groups based on their type of cancer. All patients will know which group they are assigned to and the medications that they are receiving. 

• Group A will enroll patients with microsatellite stable (MSI-Stable) colorectal cancer 
• Group B will enroll patients with triple negative breast cancer
• Group C will enroll patients with an MSI-High cancer that recurred or progressed after treatment with an immune checkpoint inhibitor

What the Study Entails

All patients in this study will receive EDP1503 orally for a period of 14 days, following which they will be given a combination of EDP1503 orally and the immunotherapy agent pembrolizumab. Pembrolizumab will be administered intravenously once every 3 weeks.

Participants will be followed for 2 years.

Study Sites

For more information at all sites contact Sarah Cannon Research Institute by phone 844-710-6157 or by email   

Arkansas

• Rogers: Highlands Oncology Group   

Florida

• Sarasota: Florida Cancer Specialists      

Oklahoma

• Oklahoma City: Stephenson Cancer Center   

Tennessee

• Chattanooga: Tennessee Oncology, PLLC    
• Nashville: Tennessee Oncology