NCT04974957Unknown2 期
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 71
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.
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
- •Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- •Failed with prior systemic treatments.
- •Measurable disease, as defined by RECIST v1.1
- •The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- •Life expectancy ≥ 3 months
- •Adequate hematologic and end-organ function as defined in the protocol
排除标准
- •Histologically or cytologically confirmed mixed SCLC and NSCLC.
- •Symptomatic, untreated or active central nervous system metastases.
- •Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
- •With any active autoimmune disease or history of autoimmune disease.
- •Inadequately controlled hypertension.
- •Tumor infiltration into the great vessels on imaging.
- •History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
- •Uncontrolled tumor-related pain.
- •Patients with active hepatitis B or hepatitis C
- •Severe infections within 4 weeks prior to initiation of study treatment.
- •Active tuberculosis within one year prior to initiation of study treatment.
研究组 & 干预措施
SHR-1701+BP102
Experimental
干预措施: SHR-1701；BP102 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 2 years
次要结局
- Progression free survival (PFS)(2 years)
- Disease control rate (DCR)(2 years)
- Duration of response (DOR)(2 years)
- Overall survival (OS)(2 years)
研究者
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