A Phase I, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Incidence of dose-limiting toxicities (DLTs; Part A)
研究概览
简要总结
The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma.
详细描述
Part A of the study will evaluate the safety and tolerability of BP2202 and determine recommended phase 2 dose. Part B of the study will further evaluate safety and explore the potential anti-myeloma activity of BP2202 at recommended phase 2 dose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Multiple Myeloma with relapsed or refractory disease.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •Adequate organ function.
- •Have measurable disease
排除标准
- •Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of Multiple Myeloma.
- •Known second malignancy that is progressing or requires active treatment or may interfere with study endpoints.
研究组 & 干预措施
BP2202
干预措施: BP2202 (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs; Part A)
时间窗: Up to 6 weeks
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to BP2202
Incidence of adverse events (AEs; Parts A and B)
时间窗: Up to approximately 2 years
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
次要结局
- Overall Response Rate (Parts A and B)(Up to approximately 2 years)
- Duration of Response (DoR) (Parts A and B)(Up to approximately 2 years)
- Disease Control Rate (DCR) (Parts A and B)(Up to approximately 2 years)