A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer or Checkpoint Inhibitor Relapsed Tumors
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.
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.
For more information at all sites contact Sarah Cannon Research Institute by phone 844-710-6157 or by email
- Rogers: Highlands Oncology Group
- Sarasota: Florida Cancer Specialists
- Oklahoma City: Stephenson Cancer Center
- Chattanooga: Tennessee Oncology, PLLC
- Nashville: Tennessee Oncology
Women or men, age 18 years or older, are eligible if they:
- Have advanced or metastatic solid tumors with disease progression after treatment that meets one of the following:
- microsatellite stable (MSI-Stable) colorectal cancer
- triple negative breast cancer
- MSI-High cancer that recurred or progressed after treatment with an immune checkpoint inhibitor
- Are able to provide tumor tissue sample since their most recent anticancer regimen or newly obtained tumor tissue not previously irradiated.
- Those with prior malignancies will be reviewed by study enrollment team.
The study is not open to patients with the following:
- received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent and discontinued that treatment due to a severe immune-related adverse event
- Having impaired cardiac function or significant cardiac diseases
- Who have uncontrolled active severe systemic infections
- With active Central Nervous System metastases and/or meningeal cancer
- With severe hypersensitivity to pembrolizumab or any of its components
- With a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy
- With uncontrolled vomiting or diarrhea that could interfere with the gastrointestinal exposure to EDP1503.
- Having an active autoimmune disease that required systemic treatment in the past 2 years.