An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 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, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
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;
- •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 active central nervous system metastases or meningeal metastases;
- •Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
- •History of serious cardiovascular and cerebrovascular diseases;
- •Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
- •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-9839
three stages: dose escalation, dose expansion and efficacy expansion.
干预措施: SHR-9839 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
时间窗: On the first day of each week,4 weeks is a treatment cycle
Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment
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-9839 by way of adverse events (CTCAE v5.0).
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, PD, efficacy data in dose escalation and dose expansion stages.
次要结局
- PK parameter: Tmax of SHR-9839(approximately 10 months)
- PK parameter: AUC0-t of SHR-9839(Approximately 10 months)
- Duration of response (DoR)(Approximately within 36 months)
- PK parameter: AUC0-∞ of SHR-9839(Approximately 10 months)
- Disease control rate (DCR)(Approximately within 36 months)
- PK parameter: Cmax of SHR-9839(approximately 10 months)
- Immunogenicity of SHR-9839(Approximately 12 months)
- Overall response rate (ORR)(Approximately within 36 months)
- Progression-free survival (PFS)(Approximately within 36 months)