NCT05943041CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 22 Jun 2023
- Start date
- 28 Apr 2023
- Primary completion date
- 22 Dec 2023
- Lead sponsor
- GILongevity
- Diseases
- Colorectal cancer
- NCT number
- NCT05943041
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 28 Apr 2023 to the primary completion date, 22 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of immunosuppressant within the 1 month of initial administration
- Subjects who have completed a course of antibiotics within the one month prior to screening
Other illness
- 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
- Known HIV infection, or active infection with hepatitis B or C
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.