A Phase 1 interventional study of GB104(Level 1) and GB104(Level 2) in Solid Tumor, Colorectal Cancer and Sigmoid Colon Cancer, sponsored by GI Biome, Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by GI Biome, Inc. · Phase 1, Interventional, and Treatment
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 9 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with GI Biome, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:
Exclusion Criteria:
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)
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)
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)
One capsule QD oral administration for 28 days
Three capsules QD oral administration for 28 days
Five capsules QD oral administration for 28 days
Incidence of DLT(Dose-Limiting Toxicity) at week 4
Time frame: 4 weeks
Incidence of Adverse Events from baseline to 8 weeks
Time frame: assessed up to 8 weeks
Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks
analyzed by quantitative PCR
Time frame: assessed up to 8 weeks
Changes in composition of gut microbiota in fecal samples from baseline to 8 weeks
analyzed by 16S rRNA gene amplicon sequencing
Time frame: assessed up to 8 weeks
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
Time frame: assessed up to 8 weeks
Changes in quality of life improvement from baseline to 8 weeks
analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire
Time frame: assessed up to 8 weeks
Changes of LARS(Low Anterior Resection Syndrome) score from baseline to 8 weeks
analyzed by LARS questionnaire
Time frame: assessed up to 8 weeks
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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