A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events (AEs).
研究概览
简要总结
This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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
- •At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- •Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
- •Is willing to provide an adequate tumor sample.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
排除标准
- •Presence of dysphagia or other factors impairing oral administration of SHR
- •Has previously been treated with any enhancer of zeste homolog inhibitors.
- •Uncontrolled or significant cardiovascular disease.
- •Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- •Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
- •History of known hypersensitivity to SHR2554 or excipients.
- •Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
- •Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.
- •Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
- •Psychological, social, familial, or geographical factors that would prevent regular follow-up.
研究组 & 干预措施
Treatment group A
干预措施: SHR2554 Tablets (Drug)
Treatment group A
干预措施: SHR-A1811 Injection (Drug)
Treatment group B
干预措施: SHR2554 Tablets (Drug)
Treatment group B
干预措施: SHR-A1904 Injection (Drug)
Treatment group C
干预措施: SHR2554 Tablets (Drug)
Treatment group C
干预措施: SHR-1701 Injection (Drug)
Treatment group D
干预措施: SHR2554 Tablets (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs).
时间窗: Up to approximately 2 years.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Dose Limited Toxicity (DLT).
时间窗: Up to Day 21.
Incidence and severity of serious adverse events (SAEs).
时间窗: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Objective response rate (ORR) by the investigator assessment.
时间窗: Up to approximately 1 year.
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.
次要结局
- Overall survival (OS) assessed by the investigator.(Approximately 24 months.)
- Duration of objective tumor response (DoR).(Approximately 24 months.)
- Progression-free survival (PFS).(Approximately 24 months.)
- Disease control rate (DCR).(Approximately 24 months.)