NCT06737731招募中1 期
A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors
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
- 300
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in 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
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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- •Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- •Have at least one measurable tumor lesion per RECIST v1.1;
- •ECOG performance score of 0-1;
- •Life expectancy ≥ 3 months;
- •Adequate bone marrow and organ function.
排除标准
- •Subjects with active central nervous system metastases or meningeal metastases;
- •History of serious cardiovascular and cerebrovascular diseases;
- •Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- •Severe infection within 4 weeks prior to the first dose;
- •Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- •Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
研究组 & 干预措施
SHR-1681
Experimental
干预措施: SHR-1681 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 12 months.
Maximum administered dose (MAD)
时间窗: 12 months.
Recommended Phase 2 dose (RP2D)
时间窗: 12 months.
Incidence and severity of adverse events (AEs)
时间窗: Approximately 3 years.
Incidence and severity of serious adverse events (SAEs)
时间窗: Approximately 3 years.
次要结局
- Time to maximum concentration (Tmax) of SHR-1681(Approximately 3 years.)
- Maximum concentration (Cmax) of SHR-1681(Approximately 3 years.)
- Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681(Approximately 3 years.)
- Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681(Approximately 3 years.)
- Anti-SHR-1681 antibody (ADA) of SHR-1681(Approximately 3 years.)
- Overall response rate (ORR)(Approximately 3 years.)
- Duration of response (DoR)(Approximately 3 years.)
- Disease control rate (DCR)(Approximately 3 years.)
- Progression-free survival (PFS)(Approximately 3 years.)
- Overall survival (OS)(Approximately up to 5 years after the last subject enrolled.)
研究者
研究点 (2)
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