NCT05943041

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GILongevity · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Colorectal Cancer
• Sigmoid Colon Cancer
• Rectosigmoid Junction Cancer
• Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	GB104(Level 1)	One capsule QD oral administration for 28 days
DRUG	GB104(Level 2)	Three capsules QD oral administration for 28 days
DRUG	GB104(Level 3)	Five capsules QD oral administration for 28 days

Timeline

• Start date: 2023-04-28
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2023-07-12
• Last updated: 2025-02-14

Locations

1 site across 1 country: South Korea