An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DCR
研究概览
简要总结
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent form.
- •Age 18 to 75 years (inclusive), male or female.
- •Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
- •Eligible participants of childbearing participants(male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
排除标准
- •Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
- •Participants who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
- •In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
- •Other active uncontrolled infection.
- •Known alcohol or drug dependence.
- •Participants with mental disorders or poor compliance.
- •Women who are pregnant or breastfeeding.
- •Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
研究组 & 干预措施
Single Arm
VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W
干预措施: VG2025 (Drug)
结局指标
主要结局
DCR
时间窗: up to 36 months
Disease control rate (DCR)
ORR
时间窗: up to 36 months
Objective response rate (ORR)
次要结局
- PFS(up to 36 months)
- OS(up to 36 months)
- Correlation between VG2025 efficacy and CEA levels(up to 36 months)
- Immune-related indicators(up to 36 months)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(up to 36 months)