NCT04485065暂停1 期
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS subjects with higher risk;
- •Age ≥ 18 years old;
- •Eastern Cooperative Oncology Group score of 0~1;
- •Not suitable for or refuse to receive HSCT;
- •Newly diagnosed MDS subjects;
- •Adequate organ function;
- •Subjects should take effective contraceptive measures
- •Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
排除标准
- •Subject who has transformed from MDS to AML.
- •Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
- •MDS subjects with lower risk.
- •Subjects who have received chemotherapy.
- •Prior exposure to any anti-CD47 or anti-SIRPα agents.
- •Subjects participating in another interventional clinical study.
研究组 & 干预措施
IBI188+azacitidine
Experimental
干预措施: IBI188+azacitidine (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 24 months
To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Complete response rate (CR) and duration of complete response (DoCR)
时间窗: 24 months
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.
次要结局
- Complete response rate (CR) and duration of complete response (DoCR)(24 months)
研究者
研究点 (1)
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