A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 17
- 主要终点
- Maximum tolerated dose (MTD) or maximum administered dose (MAD).
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-A2009 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 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 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);
- •ECOG performance status of 0-1;
- •Life expectancy ≥ 12 weeks;
- •Adequate bone marrow and organ function .
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
排除标准
- •Patients with symptomatic central nervous system metastases or meningeal metastases;
- •Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- •Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
- •History of serious cardiovascular and cerebrovascular diseases;
- •Severe infection within 4 weeks prior to the first dose;
- •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-A2009 for Injection will be administrated per dose level in which the patients are assigned.
干预措施: SHR-A2009 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or maximum administered dose (MAD).
时间窗: From Day 1 to Day 21
Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.
Recommended Phase 2 dose (RP2D)
时间窗: From Day 1 to 90 days after last dose
RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
时间窗: From Day 1 to 90 days after last dose
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
次要结局
- Tmax of SHR-A2009(approximately 6 months)
- Cmax of SHR-A2009(approximately 6 months)
- AUC0-t of SHR-A2009(approximately 6 months)
- AUC0-∞ of SHR-A2009(approximately 6 months)
- Immunogenicity of SHR-A2009(approximately 9 months)
- Overall response rate (ORR)(approximately within 36 months)
- Duration of response (DoR)(approximately within 36 months)
- Disease control rate (DCR)(approximately within 36 months)
- Progression-free survival (PFS)(approximately within 36 months)