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

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

Study Overview

• Status: Completed
• Conditions: Cancer; Colorectal Cancer; Rectal Cancer; Solid Tumor; Sigmoid Colon Cancer; Rectosigmoid Junction Cancer
• Intervention / Treatment: Drug: GB104(Level 1); Drug: GB104(Level 2); Drug: GB104(Level 3)

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 81 Ilwon-ro
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects who sign on an informed consent form willingly
2. Subjects who have histological and radiological diagnosis of colorectal cancer
3. Males and females aged between 19 and 80 years at the time of screening

4. 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
5. Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
6. 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
7. 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)
8. 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:

1. 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
2. Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
3. Previous history of immunosuppressant within the 1 month of initial administration
4. Known HIV infection, or active infection with hepatitis B or C
5. Subjects who have completed a course of antibiotics within the one month prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GB104: Dose level 1; Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.	Drug: GB104(Level 1); One capsule QD oral administration for 28 days
Experimental: GB104: Dose level 2; Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.	Drug: GB104(Level 2); Three capsules QD oral administration for 28 days
Experimental: GB104: Dose level 3; Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.	Drug: GB104(Level 3); Five capsules QD oral administration for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of DLT(Dose-Limiting Toxicity) at week 4	4 weeks
Incidence of Adverse Events from baseline to 8 weeks	assessed up to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks	analyzed by quantitative PCR	assessed up to 8 weeks
Changes in composition of gut microbiota in fecal samples from baseline to 8 weeks	analyzed by 16S rRNA gene amplicon sequencing	assessed up to 8 weeks
Changes in immune status from baseline to 8 weeks	Immune response activation factors(cytokine); Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry	assessed up to 8 weeks
Changes in quality of life improvement from baseline to 8 weeks	analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire	assessed up to 8 weeks
Changes of LARS(Low Anterior Resection Syndrome) score from baseline to 8 weeks	analyzed by LARS questionnaire	assessed up to 8 weeks

Collaborators and Investigators

• Sponsor: GI Biome, Inc.
• Investigators: Principal Investigator: Woo Yong Lee, M.D., Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Sigmoid Diseases; Colonic Neoplasms; Colorectal Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: GB-X01-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No