NCT06404905招募中1 期
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
详细描述
Overall study design:
This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.
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
盲法说明
Open Label
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
- •Age ≥18 at the time of signing the informed consent form, male or female;
- •Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
- •Adequate organ and hematologic function;
- •Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
- •ECOG performance status 0~1;
- •Life expectancy ≥ 3 months;
- •Good compliance and be willing to follow-up visit.
排除标准
- •Receive treatment before study as below:
- •a) Previous systematic anti-cancer therapy;
- •Active or prior documented autoimmune disease within past 2 years;
- •History of clinically significant cardiovascular disease;
- •Significant acute or chronic infections;
- •Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
- •Any prior Grade≥3 irAE while receiving immunotherapy;
- •Unstable brain metastasis or meningeal metastasis with clinical symptoms;
- •Patients with mental disorders or poor compliance;
- •Known alcohol or drug abuse;
- •Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.
研究组 & 干预措施
BT02 treatment
Experimental
BT02 given intravenously administer in patients with advanced solid tumors.
干预措施: BT02 monoclonal antibody injection (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: Within day 28 after administration
safety
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Within day 28 after administration
Safety
Maximum tolerated dose
时间窗: Within day 28 after administration
Maximum tolerated dose
次要结局
- Overall survival (OS)(From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.)
- Duration of response(From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.)
- Objective Response Rate (ORR)(From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.)
- The Pharmacokinetics characteristics of BT02(Within day 28 after administration)
- Progression-free survival (PFS)(From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.)
研究者
研究点 (1)
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