NCT04856774已完成1 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
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- recommended phase 2 dose (Phase Ib)
研究概览
简要总结
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
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 solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib)
- •Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
- •.Life expectancy exceeds 12 weeeks;
- •The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
- •Normal organ and marrow function;
排除标准
- •Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- •A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- •History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- •Has moderate or severe cardiovascular disease;
- •Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
- •Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
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
recommended phase 2 dose (Phase Ib)
时间窗: At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
时间窗: 2 years
次要结局
- Number of participants with treatment emergent serious adverse events (SAEs)(For each participant, from the first dose till 90 days after the last dose)
- ORR(2 years)
- Disease control rate (DCR)(2 years)
- Duration of response (DOR)(2 years)
- Time to response(TTR)(2 years)
- Dose Limiting Toxicity (DLT) (Phase 1b)(At the end of Cycle 2 (each cycle is 21 days))
- Number of participants with treatment emergent adverse events (TEAEs)(For each participant, from the first dose till 90 days after the last dose)
- Progression-free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
研究者
研究点 (1)
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