A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MTD/RP2D
研究概览
简要总结
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
详细描述
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
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.
- •Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
- •Eligible patients of childbearing potential (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
- •Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
- •Subjects 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.
- •Subjects with mental disorders or poor compliance.
- •Women who are pregnant or breastfeeding.
- •Subjects 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
3+3 design
This is an open label, single-arm trial using standard 3+3 design, in up to 30 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients
干预措施: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection (Drug)
结局指标
主要结局
MTD/RP2D
时间窗: During the 28 day DLT observation period
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 12 months
Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
次要结局
- Level of deoxyribonucleic acid (DNA)(12 months)
- Interleukin level(12 months)
- ORR(Multiple time points before and after administration)
- DCR(12 months)
- PFS(12 months)
- OS(12 months)
- Antibodies(12 months)