Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

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.

Inclusion criteria

• Subjects who sign on an informed consent form willingly
• Subjects who have histological and radiological diagnosis of colorectal cancer
• Males and females aged between 19 and 80 years at the time of screening
• Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:

• Subjects who have received adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy and have completed 3 months since the last treatments
• Subjects who have not received any adjuvant therapy and have completed 3 months from the radical colectomy
• Subjects who have undergone stoma closure and have completed 3 months after stoma closure
• Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
• Subjects who have received adjuvant chemotherapy or radiation therapy, and have completed 3 months after completing the treatment, and toxicity from previous adjuvant treatment must have recovered to NCI-CTCAE v5.0 grade 1
• Subjects who have been confirmed to have adequate hematological, renal, and hepatic function at the screening point (laboratory tests may be retested during the screening period)
• Female subjects of childbearing potential and sexually active men who agree to abstain from sexual activity or use an adequate method of contraception

Exclusion criteria

• Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months
• Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
• Previous history of immunosuppressant within the 1 month of initial administration
• Known HIV infection, or active infection with hepatitis B or C
• Subjects who have completed a course of antibiotics within the one month prior to screening