NCT06108492招募中1 期
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
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
- 170
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
研究概览
简要总结
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- •≥18 years of age, either sex;
- •Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
- •ECOG performance status of 0-1;
- •Life expectancy ≥ 2 years;
- •Adequate bone marrow and organ function.
排除标准
- •Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- •Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- •History of serious cardiovascular and cerebrovascular diseases;
- •Severe infection within 2 weeks prior to the first dose;
- •Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
- •Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
- •Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
研究组 & 干预措施
SHR-2005
Experimental
Only one arm with SHR-2005
干预措施: SHR-2005 (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
时间窗: From Day 1 to 90 days after last dose
RP2D（Recommended Phase 2 dose）
时间窗: From Day 1 to 90 days after last dose
Incidence of dose limiting toxicities (DLTs)
时间窗: From Day 1 to Day 21
Maximum tolerated dose (MTD)
时间窗: From Day 1 to Day 21
次要结局
- PK parameter: Tmax of SHR-2005(approximately 24 months)
- Duration of response (DoR)(approximately within 36 months)
- PK parameter: AUC0-∞ of SHR-2005(approximately 24 months)
- Progression-free survival (PFS)(approximately within 36 months)
- PK parameter: Cmax of SHR-2005(approximately 24 months)
- Amount_recovered and Percent_recovered(approximately 24 months)
- Immunogenicity of SHR-2005(approximately 24 months)
- Disease control rate (DCR)(approximately within 36 months)
研究者
研究点 (1)
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