NCT03736889招募中2 期
A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
BeiGene55 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 55
- 主要终点
- Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
研究概览
简要总结
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having histological confirmed diagnosis of malignancy
- •Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- •Having received prior cancer therapy regimen(s) for advanced disease.
- •At least 1 measurable lesion as defined per RECIST Version (v) 1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Adequate organ function
排除标准
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Active leptomeningeal disease or uncontrolled brain metastasis.
- •Clinically significant pleural effusion, pericardial effusion or ascites
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •Any active malignancy
- •Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
- •Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
- •Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
- •Having severe chronic or active infections
- •A known history of human immunodeficiency virus infection
- •Child - Pugh B or greater cirrhosis
- •Any major surgical procedure ≤ 28 days before the first dose of study drug
- •Prior allogeneic stem cell transplantation or organ transplantation
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab (BGB-A317) Injection
Experimental
干预措施: Tislelizumab (BGB-A317) (Drug)
结局指标
主要结局
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
时间窗: Up to 2 years
次要结局
- Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to 2 years)
- Progression-free survival assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to 2 years)
- Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to 2 years)
- Disease control rate assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to 2 years)
- Overall survival(Up to 2 years)
- Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to 2 years)
- Safety and tolerability assessment per the number of participants experiencing Treatment-Emergent Adverse Event (TEAE) as assessed by CTCAE v5.0(Up to 2 years)
研究者
研究点 (55)
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