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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events from baseline to 8 weeks
研究概览
简要总结
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GB104: Dose 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.
干预措施: GB104(Level 1) (Drug)
GB104: Dose 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.
干预措施: GB104(Level 2) (Drug)
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.
干预措施: GB104(Level 3) (Drug)
结局指标
主要结局
Incidence of Adverse Events from baseline to 8 weeks
时间窗: assessed up to 8 weeks
Incidence of DLT(Dose-Limiting Toxicity) at week 4
时间窗: 4 weeks
次要结局
未报告次要终点