A Single-arm, Open, Dose-increasing Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 in Patients with Her2-positive Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of BAT1006 after single and multiple dosing; 2) To study the immunogenicity of BAT1006; 3) Preliminary evaluation of anti-tumor efficacy of BAT1006.
详细描述
This trial is an open phase I, dose-escalation clinical study. The first administration period was the 21st day, namely the DLT observation period. DLT observation was conducted to explore the safety, tolerability, pharmacokinetics and immunogenicity of MTD, single administration. After the observation period of DLT, the drug was administered once every 3 weeks, and the tolerance, pharmacokinetics, immunogenicity and preliminary effectiveness of multiple administration were evaluated. If some dose groups show better efficacy, the investigator and the sponsor may select 1-2 dose groups that have been found to have efficacy after negotiation and discussion for extended study to further explore the safety and efficacy of the drug.
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 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
A1/3mg/kg
Dose: 3mg/kg
干预措施: BAT1006 (Drug)
A2/6mg/kg
Dose: 6mg/kg
干预措施: BAT1006 (Drug)
A3/10mg/kg
Dose: 10mg/kg
干预措施: BAT1006 (Drug)
A4/15mg/kg
Dose: 15mg/kg
干预措施: BAT1006 (Drug)
A5/20mg/kg
Dose: 20mg/kg
干预措施: BAT1006 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 21 days
Dose-limiting toxicity (DLT) is defined as any of the following adverse events (CTCAE Version 5.0 classification for the evaluation of adverse effects) that occur during the first treatment cycle that are definitely or possibly related to the investigatory drug: 1. Grade ≥3 non-hematological toxicity (nausea, vomiting and diarrhea can be relieved within 3 days after supportive treatment, except for infusion reactions that can be recovered within 2 hours after symptomatic treatment); 2. Hematological toxicity 2.1 Grade ≥3 neutropenia with fever, or grade 3 thrombocytopenia with significant bleeding; 2.2 Grade ≥4 hematologic toxicity: thrombocytopenia for more than 5 days, or grade 4 neutropenia for more than 7 days; 3. LVEF decreased by \> 15% or LVEF value decreased by \< 50% from baseline; 4. In the case of other SAE or AE that the researcher considers unacceptable, the researcher will communicate with the sponsor to decide whether to judge it as DLT.
Maximum tolerance dose（MTD）
时间窗: 21 days
MTD is defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period
次要结局
未报告次要终点