Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Atezolizumab in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
研究概览
简要总结
A Phase 1 Open-label Dose Escalation Study of BDB001 in Combination with Atezolizumab in Subjects with Advanced Solid Tumors
详细描述
This clinical trial is a study of an experimental drug called BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system.
The primary objectives of this study are to evaluate the safety and tolerability of BDB001 in combination with atezolizumab (Tecentriq) in subjects with unresectable or metastatic solid tumors who have relapsed or are refractory to standard treatment or for whom there is no approved therapy.
This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 in combination with atezolizumab.
The study will be conducted in two separate but independent parts: a dose escalation part with BDB001 and atezolizumab and a dose expansion part of BDB001 in combination with atezolizumab.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation of BDB001 with atezolizumab
This part of the study will follow a traditional 3+3 dose escalation design.
Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of BDB001 with atezolizumab is reached.
干预措施: BDB001 (EIK1001) (Drug)
Dose Escalation of BDB001 with atezolizumab
This part of the study will follow a traditional 3+3 dose escalation design.
Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of BDB001 with atezolizumab is reached.
干预措施: Atezolizumab (Drug)
Dose Expansion of BDB001 with atezolizumab
At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data.
A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part.
干预措施: BDB001 (EIK1001) (Drug)
Dose Expansion of BDB001 with atezolizumab
At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data.
A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
时间窗: up to 21 months
Safety and tolerability of BDB001 in combination with atezolizumab as measured by the incidence of adverse events and any dose limiting toxicities (DLT)
Determine Maximum Tolerated Dose (MTD) or recommended Phase 2 Dose (RP2D)
时间窗: from first dose to 21 days after first dose for each patient
Determination of the MTD or RP2D by assessing the frequency and severity of adverse events related to BDB001 when given in combination with atezolizumab using CTCAE version 5.0 to categorize adverse event severity
次要结局
- Radiographic Determination of Tumor Response after BDB001 in combination with atezolizumab dosing(At the beginning of Cycle 3 (every cycle is 21 days) up to 30 months after the first dose for each patient)