An Open-label, Multicenter, Phase 1 Clinical Trial to Evaluate MTD, Safety, PK/PD and Preliminary Anti-tumor Activity of SB17170 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Failed Standard of Care
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety and tolerability of SB17170
研究概览
简要总结
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
详细描述
This is an open-label, multicenter, Phase 1 clinical trial to evaluate the maximum tolerated dose, safety, pharmacokinetic/pharmacodynamic characteristics and preliminary anti-tumor activity of SB17170 when administered alone(1a) and co-administered with standard of care(1b) to patients with locally advanced or metastatic solid tumors who have failed standard of care.
1 cycle of treatment of this clinical trial is 21 days, and tumors are assessed every 2 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •A patient with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors.
- •A person who has failed the known standard of care or has developed resistance to the standard of care and no longer has applicable standard of care
- •A patient with at least one measurable lesion according to the RECIST v1.1 criteria.
- •A person with Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or
- •Those with an expected survival period of 3 months or more at the discretion of of the investigator.
排除标准
- •A patient who has received drugs targeting High Mobility Group Box 1 (HMGB1).
- •A patient who has received or is undergoing chemotherapy (including chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted therapy, biological products, and tumor embolization) within 28 days from the first administration date of the investigational drug.
- •A person who needs to take contraindicated drugs or is expected to take them during the study period.
研究组 & 干预措施
Cohort 1
SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort
干预措施: SB17170 (Drug)
Cohort 2
SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort
干预措施: SB17170 (Drug)
Cohort 3
SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort
干预措施: SB17170 (Drug)
结局指标
主要结局
Safety and tolerability of SB17170
时间窗: At the end of Cycle 1 (each cycle is 21 days)
Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D).
次要结局
- Pharmacokinetic(AUC)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
- Pharmacodynamics(TIL)(At Day1 and D22 of Cycle 1 (each cycle is 21 days))
- Pharmacokinetic(Cmax)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
- Pharmacokinetic(Tmax)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
- The anti-tumor activity with RECIST v1.1(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks)
- Pharmacodynamics(S100A8)(At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days))
- Pharmacodynamics(MDSC)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
- Pharmacodynamics(S100A9)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
- Pharmacodynamics(CXCL8)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
- Pharmacodynamics(TAM)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
- Pharmacodynamics(T cell activation)(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))
- Pharmacodynamics(PD-L1)(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))
- Pharmacodynamics(High Mobility Group Box 1 )(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))