A Phase I Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics, Biological Effects and Initial Efficacy of Recombinant Oncolytic Virus M1 for Injection (VRT106) in the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
研究概览
简要总结
To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.
详细描述
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.
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
- •Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- •Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- •Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- •Have at least one injectable lesion.
- •An Eastern Cooperative Oncology Group (ECOG) score of 0-
- •An estimated survival time of ≥ 12 weeks.
排除标准
- •Subject has received any anti-tumor treatment 4 weeks before using the IMP.
- •Subject has received any prior oncolytic viruses or other gene therapies.
- •Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- •Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
研究组 & 干预措施
VRT106
VRT106
干预措施: VRT106 (Biological)
结局指标
主要结局
Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
时间窗: About 2 years
Incidence rate of TEAE
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
时间窗: About 2 years
Incidence rate of DLT
次要结局
- Assess the immunogenicity of intratumoral injection of VRT106.(About 2 years)
- Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.(About 2 years)
- Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.(About 2 years)
- Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.(About 2 years)