Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
NCT05943041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-02-14
Summary
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
Conditions
- Solid Tumor
- Colorectal Cancer
- Sigmoid Colon Cancer
- Rectosigmoid Junction Cancer
- Cancer
- Rectal Cancer
Interventions
- 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
Sponsors & Collaborators
-
GILongevity
lead INDUSTRY
Principal Investigators
-
Woo Yong Lee, M.D., Ph.D. · Samsung Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-28
- Primary Completion
- 2023-12-22
- Completion
- 2023-12-22
Countries
- South Korea
Study Locations
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