NCT04280328已完成1 期
An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
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
- 7
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
研究概览
简要总结
This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory myeloma.
- •Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two.
- •Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies.
- •Active myeloma requiring systemic treatment.
- •Measurable disease per protocol.
- •ECOG performance status of 0 -
- •Life expectancy of at least 3 months.
排除标准
- •POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
- •History of select prior malignancies.
- •Previous intolerance to daratumumab or any study drug.
- •Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant.
- •Have an active infection or serious comorbid medical condition.
- •Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.
- •Female participants pregnant or breast-feeding.
- •Screening chemistry and blood counts within protocol limits
- •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
研究组 & 干预措施
Ciforadenant in combination with daratumumab
Experimental
Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
干预措施: Ciforadenant (Drug)
Ciforadenant in combination with daratumumab
Experimental
Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
干预措施: daratumumab (Drug)
结局指标
主要结局
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
时间窗: 28 days following first administration of ciforadnenat in combination with daratumumab
Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab
次要结局
- Overall response rate.(From start of treatment to end of treatment, up to 24 months)
- Minimal Residual Disease.(From start of treatment to end of treatment, up to 24 months)
- Progression free survival.(Up to 2 years after end of treatment.)
- Disease control rate.(From start of treatment to end of treatment, up to 24 months)
- Time to next therapy.(Up to 2 years after end of treatment.)
- Duration of response.(From start of treatment to end of treatment, up to 24 months)
研究者
研究点 (1)
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