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Trial Title:
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
NCT ID:
NCT05943041
Condition:
Solid Tumor
Colorectal Cancer
Sigmoid Colon Cancer
Rectosigmoid Junction Cancer
Cancer
Rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Sigmoid Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Sequential Group Assignment (3+3 model)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GB104(Level 1)
Description:
One capsule QD oral administration for 28 days
Arm group label:
GB104: Dose level 1
Intervention type:
Drug
Intervention name:
GB104(Level 2)
Description:
Three capsules QD oral administration for 28 days
Arm group label:
GB104: Dose level 2
Intervention type:
Drug
Intervention name:
GB104(Level 3)
Description:
Five capsules QD oral administration for 28 days
Arm group label:
GB104: Dose level 3
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
81 Ilwon-ro
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Woo Yong Lee, M.D., Ph.D.
Phone:
02-3410-0261
Email:
lwy555@skku.edu
Contact backup:
Last name:
Dae Hee Pyo, M.D., Ph.D.
Phone:
02-3410-0261
Email:
daehee.pyo@samsung.com
Start date:
April 28, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
GI Biome, Inc.
Agency class:
Industry
Source:
GI Biome, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943041
