Clinical trial · Interventional
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
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
NCT05943041CI-TRIAL-00086014completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectosigmoid Junction Cancer | — | UNRESOLVED | — |
| Sigmoid Colon Cancer | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GB104(Level 1) | Drug | — | UNRESOLVED |
| GB104(Level 2) | Drug | — | UNRESOLVED |
| GB104(Level 3) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- GB104: Dose level 1
- 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.
- interventionNames
- Drug: GB104(Level 1)
- type
- EXPERIMENTAL
- label
- GB104: Dose level 2
- 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.
- interventionNames
- Drug: GB104(Level 2)
- type
- EXPERIMENTAL
- label
- GB104: Dose level 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.