A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for 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
- 12
- 试验地点
- 3
- 主要终点
- Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
研究概览
简要总结
A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or 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 multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- •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 least 18 years of age, inclusive, at the Screening Visit.
- •Have at least one measurable lesion.
- •An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
- •An estimated survival time of ≥ 12 weeks.
排除标准
- •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 any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
- •Subject has received systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
- •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
M1-c6v1 intravenous injection
M1-c6v1 will be administered through IV drip
干预措施: M1-c6v1 (Biological)
结局指标
主要结局
Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
时间窗: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors
时间窗: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.
时间窗: About 2 years
Incidence of DLT
次要结局
- Assess the immunogenicity of intravenous administration of M1-c6v1.(About 2 years)
- Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.(About 2 years)
- Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.(About 2 years)