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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05943041
Other study ID # GB-X01-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 28, 2023
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source GI Biome, Inc.
Contact Sujin Kim, Ph.D.
Phone +82-31-8035-3240
Email sujin.kim@gi-biome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

Drug:
GB104(Level 1)
One capsule QD oral administration for 28 days
GB104(Level 2)
Three capsules QD oral administration for 28 days
GB104(Level 3)
Five capsules QD oral administration for 28 days

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul Gangnam-gu

Sponsors (1)

Lead Sponsor Collaborator
GI Biome, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks analyzed by quantitative PCR assessed up to 8 weeks
Other 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
Other 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
Other 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
Other Changes of LARS(Low Anterior Resection Syndrome) score from baseline to 8 weeks analyzed by LARS questionnaire assessed up to 8 weeks
Primary Incidence of DLT(Dose-Limiting Toxicity) at week 4 4 weeks
Primary Incidence of Adverse Events from baseline to 8 weeks assessed up to 8 weeks
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