Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943041
• Other study ID #: GB-X01-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Cancer
• Sigmoid Colon Cancer
• Sigmoid Neoplasms
• Solid Tumor

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