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Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Cancer Clinical Trial

Official title:
Open-label, Single-center, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of GB104, and Explore Gut Microbial Composition in Patients Who Completed Curative Colectomy and Planned Therapy of Colorectal Cancer

Clinical Trial Summary

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

Clinical Trial Description

This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05943041
Study type Interventional
Source GI Biome, Inc.
Contact Sujin Kim, Ph.D.
Phone +82-31-8035-3240
Email sujin.kim@gi-biome.com
Status Recruiting
Phase Phase 1
Start date April 28, 2023
Completion date December 31, 2023
View Details
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