Multi-center, Open Label, Phase Ib Clinical Trial to Evaluate Safety, Tolerance and Efficacy of TASO(TGF-β2 Targeting Anti-sense Oligonucleotide)-001 in Combination With Recombinant Interleukin-2 in Advanced or Metastatic Solid Tumor
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 MTD (Tolerability)
研究概览
简要总结
To evaluate safety, tolerance and efficacy of TASO(TGF-β2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in advanced or metastatic solid tumor and to find appropriate dose for phase 2 clinical trial.
详细描述
This clinical trial is conducted by dividing into two cohorts according to the dose of the test drug, starting with Cohort 1, and confirming whether DLT occurs until 14 days after the 2nd cycle of the test drug administration and proceed with Cohort 2 after discussion by DMC. Recruitment of each cohort is applied with a 3+3 design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adults over 19 years old on the day of consent
- •Pathologically confirmed solid cancer
- •Patients with advanced or metastatic solid timour failed or tolerable with standard therapy.
- •A person who has a tumor lesion that can safely undergo tissue biopsy during administration of the test drug and can provide tissues stored at the clinical trial agency or tissue obtained from a tissue biopsy conducted before the first administration of the test drug
排除标准
- •Those who have been treated with IL-2 or TGF-β inhibitors other than test drugs (e.g., anti-sense oligonucleotide, antibody, TGF-b receptor inhibitor)
- •Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- •Immunotherapy within 2 weeks prior to first dose of study treatment.
- •Major surgery within 4 weeks prior to first dose of study treatment.
研究组 & 干预措施
TASO-001
level 1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)(3+3) next than level 2 or level -1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)
干预措施: TASO-001((TGF-β2 targeting anti-sense oligonucleotide) (Drug)
TASO-001
level 1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)(3+3) next than level 2 or level -1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)
干预措施: Aldesleukin (Combination Product)
结局指标
主要结局
Incidence of MTD (Tolerability)
时间窗: 4weeks(DLT)
MTD and RP2D are determined
次要结局
- PFS(Progression free survival)(every 8 weeks, up to 14 days after the last dose of TASO-001)
- DCR(Disease control rate)(every 8 weeks, and up to 14 days after the last dose of TASO-001)
- OS(Overall survival)(every 8 weeks, up to 14 days after the last dose of TASO-001)
- ORR(objective response rate)(every 8 weeks, and up to 14 days after the last dose of TASO-001)
- DoR(Duration of response)(every 8 weeks, and up to 14 days after the last dose of TASO-001)