An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A Flat Dose Escalation: RO7297089
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
干预措施: RO7297089 (Drug)
Arm B Split Dose Escalation: RO7297089
Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
干预措施: RO7297089 (Drug)
Arm C Step Dose Escalation: RO7297089
No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
干预措施: RO7297089 (Drug)
Phase I Expansion Stage: RO7297089
No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
干预措施: RO7297089 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
时间窗: Baseline up to 1 year 7 months
Adverse event severity graded according to NCI CTCAE v5.0
次要结局
- Area Under the Curve (AUC) of RO7297089(Cycle 1 Day 1)
- Maximum Concentration Observed (Cmax) of RO7297089(Cycle 1 Day 1, Cycle 2 Day 8)
- Half-life (t1/2) of RO7297089(Cycle 1 Day 1)
- Objective Response Rate (ORR)(Baseline up to approximately 19 months)
- Time to Maximum Concentration Observed (Tmax) of RO7297089(Cycle 1 Day 1)
- Minimum Concentration Observed (Cmin) of RO7297089(Cycle 1 Day 1, Cycle 2 Day 8)