Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

• Sponsor: GI Biome, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05943041
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor; Colorectal Cancer; Sigmoid Colon Cancer; Rectosigmoid Junction Cancer; Cancer; Rectal Cancer	Drug: GB104(Level 1); Drug: GB104(Level 2); Drug: GB104(Level 3)	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Sequential Group Assignment (3+3 model)Sequential Group Assignment (3+3 model)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 28, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of DLT(Dose-Limiting Toxicity) at week 4 [4 weeks]

2. Incidence of Adverse Events from baseline to 8 weeks [assessed up to 8 weeks]

Other Outcome Measures

1. Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks [assessed up to 8 weeks]

   analyzed by quantitative PCR

2. Changes in composition of gut microbiota in fecal samples from baseline to 8 weeks [assessed up to 8 weeks]

   analyzed by 16S rRNA gene amplicon sequencing

3. Changes in immune status from baseline to 8 weeks [assessed up to 8 weeks]

   Immune response activation factors(cytokine) Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry

4. Changes in quality of life improvement from baseline to 8 weeks [assessed up to 8 weeks]

   analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire

5. Changes of LARS(Low Anterior Resection Syndrome) score from baseline to 8 weeks [assessed up to 8 weeks]

   analyzed by LARS questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104

2. 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

3. 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)

4. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Gangnam-gu	Korea, Republic of	81 Ilwon-ro

Sponsors and Collaborators

• GI Biome, Inc.

Investigators

• Principal Investigator: Woo Yong Lee, M.D., Ph.D., Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GI Biome, Inc.
• ClinicalTrials.gov Identifier: NCT05943041
• Other Study ID Numbers: GB-X01-101
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Sigmoid Neoplasms

Study Results

No Results Posted as of Jul 12, 2023