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Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Primary Purpose

Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GB104(Level 1)
GB104(Level 2)
GB104(Level 3)
Sponsored by
GI Biome, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

GB104: Dose level 1

GB104: Dose level 2

GB104: Dose level 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of DLT(Dose-Limiting Toxicity) at week 4
Incidence of Adverse Events from baseline to 8 weeks

Secondary Outcome Measures

Full Information

First Posted
June 22, 2023
Last Updated
July 5, 2023
Sponsor
GI Biome, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05943041
Brief Title
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Biome, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer, Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Sequential Group Assignment (3+3 model)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GB104: Dose level 1
Arm Type
Experimental
Arm Description
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.
Arm Title
GB104: Dose level 2
Arm Type
Experimental
Arm Description
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.
Arm Title
GB104: Dose level 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GB104(Level 1)
Intervention Description
One capsule QD oral administration for 28 days
Intervention Type
Drug
Intervention Name(s)
GB104(Level 2)
Intervention Description
Three capsules QD oral administration for 28 days
Intervention Type
Drug
Intervention Name(s)
GB104(Level 3)
Intervention Description
Five capsules QD oral administration for 28 days
Primary Outcome Measure Information:
Title
Incidence of DLT(Dose-Limiting Toxicity) at week 4
Time Frame
4 weeks
Title
Incidence of Adverse Events from baseline to 8 weeks
Time Frame
assessed up to 8 weeks
Other Pre-specified Outcome Measures:
Title
Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks
Description
analyzed by quantitative PCR
Time Frame
assessed up to 8 weeks
Title
Changes in composition of gut microbiota in fecal samples from baseline to 8 weeks
Description
analyzed by 16S rRNA gene amplicon sequencing
Time Frame
assessed up to 8 weeks
Title
Changes in immune status from baseline to 8 weeks
Description
Immune response activation factors(cytokine) Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry
Time Frame
assessed up to 8 weeks
Title
Changes in quality of life improvement from baseline to 8 weeks
Description
analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire
Time Frame
assessed up to 8 weeks
Title
Changes of LARS(Low Anterior Resection Syndrome) score from baseline to 8 weeks
Description
analyzed by LARS questionnaire
Time Frame
assessed up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sujin Kim, Ph.D.
Phone
+82-31-8035-3240
Email
sujin.kim@gi-biome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Yong Lee, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
81 Ilwon-ro
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Yong Lee, M.D., Ph.D.
Phone
02-3410-0261
Email
lwy555@skku.edu
First Name & Middle Initial & Last Name & Degree
Dae Hee Pyo, M.D., Ph.D.
Phone
02-3410-0261
Email
daehee.pyo@samsung.com

12. IPD Sharing Statement

Learn more about this trial

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

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