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
2 other identifiers
interventional
69
2 countries
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2018
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedStudy Start
First participant enrolled
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedMarch 24, 2023
March 1, 2023
2.5 years
December 12, 2018
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Safety and tolerability of EDP1503 alone and in combination with pembrolizumab as assessed per CTCAE v5.0
Number of participants with EPD1503 related adverse events as assessed per CTCAE v5.0
2 years
Safety and tolerability of EDP1503 alone and in combination with pembrolizumab
Safety and tolerability of EDP1503 alone and in combination with pembrolizumab assessed via clinical laboratory evaluations
2 years
Evidence of anti-tumor activity of EDP1503 based on ORR
To determine preliminary evidence of anti-tumor activity of EDP1503 in patients
2 years
Secondary Outcomes (2)
Progression Free Survival
2 years
Overall Survival
2 years
Study Arms (3)
Cohort A
EXPERIMENTALCohort A includes patients with microsatellite stable (MSS) colorectal cancer (CRC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.
Cohort B
EXPERIMENTALCohort B includes patients with Triple Negative Breast Cancer (TNBC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.
Cohort C
EXPERIMENTALCohort C includes patients with non-small-cell lung cancer (NSCLC), bladder cancer; gastroesophageal (GE) cancer, any microsatellite unstable, or renal cell carcinoma (RCC) who are relapsed to prior PD-1/L1 therapy. Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab.
Interventions
4 capsules taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU)
200 mg given by intravenous (IV) infusion once every 3 weeks
Eligibility Criteria
You may qualify if:
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors who have had disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
- Have adequate organ function as defined in the clinical protocol. Specimens must be collected within 10 days prior to the start of study treatment.
- Have provided an archival tumor tissue sample obtained since the most recent prior anticancer regimen or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Measurable disease by RECIST v1.1 as assessed by the local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Metastatic disease not suitable for upfront curative-intent surgery.
- Progressive disease on previous line of therapy per treating investigator (additional specific criteria for cohort C).
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
You may not qualify if:
- Has received prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Treatment with investigational therapy within 28 days prior to initiation of study treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).
- Has received prior systemic anti-cancer therapy within 28 days or 5 half-lives, whichever is shorter prior to treatment.
- Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy may be eligible.
- Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Unstable angina or acute myocardial infarction ≤ 3 months prior to C1D1;
- Clinically significant heart disease (e.g., symptomatic congestive heart failure \[e.g., \>NYHA Class 2\]; uncontrolled arrhythmia, or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen).
- Uncontrolled active severe systemic infection requiring parenteral antibiotics within 1 week, and systemic antivirals or antifungals within two weeks prior to C1D1.
- Patients with active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Patients with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Prior malignancies:
- Patients with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (i.e. cervix, breast) may enroll irrespective of the time of diagnosis.
- Patients with a known additional malignancy that is progressing or has required active treatment within the past which may interfere with the interpretation of the study. Cancer treated with curative intent \< 5 years previously will not be allowed unless approved by the Sponsor. Cancer treated with curative intent \> 5 years previously and without evidence of recurrence will be allowed.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evelo Biosciences, Inc.lead
- SCRI Development Innovations, LLCcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (8)
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0A9, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
CHU de Québec - Université Laval
Québec, G1R 2J6, Canada
Related Publications (1)
Wang JS, Arrowsmith ER, Beck JT, Friedmann J, Jamal R, McHale D, Gardner H, Chisamore MJ, Ulahannan SV. Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor-relapsed tumors. Invest New Drugs. 2025 Aug;43(4):894-903. doi: 10.1007/s10637-025-01573-0. Epub 2025 Aug 20.
PMID: 40830709DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanna Bendell, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 14, 2018
Study Start
December 19, 2018
Primary Completion
June 30, 2021
Study Completion
October 31, 2021
Last Updated
March 24, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share