Trials / Completed
CompletedNCT03775850
A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Evelo Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Colorectal Cancer Metastatic
- Triple Negative Breast Cancer
- Non Small Cell Lung Cancer
- Bladder Cancer
- GastroEsophageal Cancer
- Renal Cell Carcinoma
- MSI-H
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EDP1503 | 4 capsules taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU) |
| BIOLOGICAL | Pembrolizumab | 200 mg given by intravenous (IV) infusion once every 3 weeks |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2021-06-30
- Completion
- 2021-10-31
- First posted
- 2018-12-14
- Last updated
- 2023-03-24
Locations
8 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03775850. Inclusion in this directory is not an endorsement.