Spots Global Cancer Trial Database for Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
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Trial Identification
Brief Title: Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
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
Study ID: NCT05943041
Study Description
Brief Summary: Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
Detailed 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.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Samsung Medical Center, Seoul, Gangnam-gu, Korea, Republic of
Contact Details
Name: Woo Yong Lee, M.D., Ph.D.
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
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