Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer
About this trial
This is an interventional treatment trial for Solid Tumor
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
GB104: Dose level 1
GB104: Dose level 2
GB104: Dose level 3
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.