NCT07558915招募中1 期
An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Life expectancy of at least 12 weeks.
- •Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.
- •Measurable disease.
排除标准
- •Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.
- •Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.
- •Prior allogeneic SCT.
- •Prior solid organ transplantation.
研究组 & 干预措施
RO7851624
Experimental
Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage.
干预措施: RO7851624 (Drug)
研究者
研究点 (1)
Loading locations...
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