Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
One capsule QD oral administration for 28 days
Three capsules QD oral administration for 28 days
Five capsules QD oral administration for 28 days
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Incidence of DLT(Dose-Limiting Toxicity) at week 4
Time frame: 4 weeks
Incidence of Adverse Events from baseline to 8 weeks
Time frame: assessed up to 8 weeks
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