A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 7
- 主要终点
- Percentage of participants with adverse events (AEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (R/R) MM who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Life expectancy of at least 12 weeks
- •Measurable disease, as defined by the protocol
- •Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
- •Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment
排除标准
- •Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
- •Prior allogeneic stem cell or solid organ transplantation
- •Autologous stem cell transplantation within 100 days prior to initiation of study treatment
- •Significant cardiovascular disease
- •Known clinically significant liver disease
- •Active or history of autoimmune disease or immune deficiency
- •Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
- •Primary or secondary plasma cell leukemia
- •Current CNS involvement by MM
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Dose escalation
Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
干预措施: XmAb24306 (Drug)
Dose escalation
Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
干预措施: Daratumumab (Drug)
Dose expansion
Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)
干预措施: XmAb24306 (Drug)
Dose expansion
Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)
干预措施: Daratumumab (Drug)
结局指标
主要结局
Percentage of participants with adverse events (AEs)
时间窗: Up to approximately 3 years
次要结局
- Prevalence of XmAb24306 anti-drug antibodies (ADAs)(Baseline to approximately 3 years)
- Objective response rate (ORR)(Baseline to approximately 3 years)
- Serum concentration of XmAb24306(Baseline to approximately 3 years)
- Incidence of XmAb24306 ADAs(Baseline to approximately 3 years)