A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
详细描述
This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Males and/or females, 18-75 years old;
- •Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Expected survival >=3 months;
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease;
- •Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI-CTCAE] v.5.0);
- •Inadequate organ or bone marrow function;
- •Pregnant or breast-feeding woman;
- •Known allergies, hypersensitivity, or intolerance to SPGL008.
研究组 & 干预措施
dose level 1 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 2 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 3 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 4 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 5 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 6 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 7 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 8 of SPGL008 （Intravenous administration）
干预措施: SPGL008 (Drug)
dose level 1 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
dose level 2 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
dose level 3 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
dose level 4 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
dose level 5 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
dose level 6 of SPGL008 （Subcutaneous administration）
干预措施: SPGL008 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: During the first cycle. Each cycle is 21 days
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.
Maximum tolerated dose (MTD)
时间窗: During the first cycle. Each cycle is 21 days
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
次要结局
- Objective Response Rate (ORR)(Up to 2 years)
- Cmax(Up to 2 years)
- Tmax(Up to 2 years)
- T1/2(Up to 2 years)
- AUC(Up to 2 years)