Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced/Metastatic Solid Tumor or Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).
Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).
Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.
Secondary objectives Dose escalation phase & Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.
Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.
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 80 Years（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
IBD0333
干预措施: IBD0333 (Biological)
结局指标
主要结局
MTD
时间窗: through study completion, an average of 1 year
Maximum tolerated dose
DRDE
时间窗: through study completion, an average of 1 year
Extended recommended dose
RP2D
时间窗: through study completion, an average of 1 year
Recommended Phase 2 dose
ORR
时间窗: through study completion, an average of 1 year
Objective response rate
Dose limiting toxicity (DLT)
时间窗: 28 days after first dose(dose-escalation phase)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
次要结局
- DCR(through study completion, an average of 1 year)
- PFS(through study completion, an average of 1 year)
- Frequency of adverse events (AEs) and SAEs(through study completion, an average of 1 year)
- ADA(through study completion, an average of 1 year)
- DoR(through study completion, an average of 1 year)
- ORR(through study completion, an average of 1 year)
- pharmacokinetic parameters(through study completion, an average of 1 year)