A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
研究概览
简要总结
This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 histologically or cytologically confirmed unresectable solid tumors;
- •At least one measurable lesion was identified per RECIST 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Adequate organ functions as defined per protocol;
- •Minimum life expectancy of 3 months.
排除标准
- •Patients with known active central nervous system (CNS) metastases;
- •History of other malignancy within the past 5 years, with exceptions defined in the protocol;
- •Patients with uncontrolled cancer pain;
- •Patients with serious cardiovascular and/or cerebrovascular diseases;
- •Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- •Patients with Severe infections within 4 weeks prior to the first dose;
- •Active pulmonary tuberculosis infection;
- •History of immunodeficiency;
- •History of autoimmune diseases;
- •The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
- •Pregnant or nursing women, or planned to become pregnant during the study period;
- •Known allergic to any component of investigational drugs.
研究组 & 干预措施
SHR-7787 combined with SHR-1316
SHR-7787 injection combined with SHR-1316 injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316
SHR-7787 injection combined with SHR-1316 injection.
干预措施: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849
SHR-7787 injection combined with SHR-4849 injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849
SHR-7787 injection combined with SHR-4849 injection.
干预措施: SHR-4849 Injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
干预措施: Etoposide injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
干预措施: Carboplatin injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
干预措施: Cisplatin injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
干预措施: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
干预措施: Etoposide injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
干预措施: Carboplatin injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
干预措施: Cisplatin injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
干预措施: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
干预措施: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
干预措施: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
干预措施: BP102 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
干预措施: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
干预措施: BP102 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
干预措施: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
干预措施: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
干预措施: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
干预措施: Carboplatin injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
干预措施: Cisplatin injection (Drug)
结局指标
主要结局
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
时间窗: Expected to be two years after the start of the study.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
时间窗: About 1 year after study initiation.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
时间窗: About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
时间窗: About 1 year after study initiation.
Objective response rate (ORR) (stage II)
时间窗: Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
时间窗: Expected to be two years after the start of the study.
次要结局
- Objective response rate (ORR)(About 1 year.)
- Duration of Response (DoR)(About 1 year.)
- Disease Control Rate (DCR)(About 1 year.)
- Progress Free Survival (PFS)(About 1 year.)
- Overall Survival (OS)(About 1 year.)