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A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors

NCT03775850 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-03-24

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • SCRI Development Innovations, LLC

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Evelo Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Johanna Bendell, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2021-06-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775850 on ClinicalTrials.gov