DRKS00023656尚未招募1 期
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose ExpansionStudy of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patientswith Relapsed/Refractory Multiple Myeloma - HPN217-3001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Major Inclusion Criteria:
- •Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
- •Measurable disease defined as at least one of the following:
- •Serum M-protein =0.5 g/dL
- •Urine M-protein =200 mg/24 hours
- •Serum free light chain (FLC) assay: Involved FLC level =10 mg/dL (=100 mg/L)
- •Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •Adequate hematologic status, including:
- •Absolute neutrophil count (ANC) =1000 cells/µL
- •Platelet count =50,000/µL (without transfusions)
- •Hemoglobin =8 g/dL
- •Adequate renal function, including:
- •a. Calculated creatinine clearance =30 mL/min using the formula of Cockcroft and Gault
- •Adequate hepatic function, including
- •Total bilirubin =1.5 × upper limit of normal (ULN), regardless of direct bilirubin
- •AST and ALT =3.0 × ULN (=5.0× ULN if due to myeloma involvement)
- •Alkaline phosphatase =3× ULN (=5.0× ULN if due to myeloma involvement)
排除标准
- •Major Exclusion Criteria:
- •Prior exposure to BCMA-targeting agents (Part 2 only)
- •Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening
研究者
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