A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for 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
- •Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- •Patients with unresectable recurrent or metastatic solid tumors;
- •There is at least one lesion could be measured;
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Adequate organ functions as defined;
- •Life expectancy ≥3 months.
排除标准
- •Patients with known active central nervous system (CNS) metastases;
- •Subjects who had other malignancy in five years before the first dose;
- •Patients with tumor-related pain that cannot be controlled as determined;
- •Patients with serious cardiovascular and cerebrovascular diseases;
- •Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- •Patients with Severe infections;
- •History of immunodeficiency;
- •History of autoimmune diseases;
- •Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy
- •Active infection;
- •Pregnant or nursing women;
- •Known history of serious allergic reactions to the investigational product or its main ingredients.
研究组 & 干预措施
Single Group: SHR-7787 injection
干预措施: SHR-7787 injection (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-7787 injection monotherapy
Recommended phase II dose
时间窗: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-7787 injection monotherapy
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
时间窗: from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of Dose Limited Toxicity (DLT)
时间窗: from first dose to 4 weeks
Incidence of Dose Limited Toxicity (DLT) described in the protocol
次要结局
- Tmax(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- Cmax(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- AUC0-t(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- t1/2(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- ADA(0.5 hour before first dose through study completion, an average of 1 year)
- ORR(from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months)