A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 19
- 主要终点
- Phase 1: Dose Limiting Toxicities (DLT)
研究概览
简要总结
This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
详细描述
The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Phase 1: Diagnosis of higher risk MDS that is either previously untreated or relapsed/refractory.
- •Phase 2: Diagnosis of higher risk MDS that is previously untreated.
- •Adequate renal and liver function.
- •Age ≥18 years.
- •Adequate performance status.
排除标准
- •Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.
- •Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
- •Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
研究组 & 干预措施
evorpacept (ALX148) + azacitidine
Phase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle
Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
干预措施: evorpacept (Drug)
evorpacept (ALX148) + azacitidine
Phase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle
Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
干预措施: azacitidine (Drug)
azacitidine
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
干预措施: azacitidine (Drug)
结局指标
主要结局
Phase 1: Dose Limiting Toxicities (DLT)
时间窗: Up to 28 days
Number of participants with a DLT
Phase 1: Recommended Phase 2 Dose (RP2D)
时间窗: Approximately 2 years
To identify the RP2D of ALX148 in combination with AZA
Phase 2: Complete response rate (CRR)
时间窗: Approximately 6 months
Number of participants achieving a complete response per International Working Group (IWG) criteria
次要结局
未报告次要终点