NCT06537310进行中（未招募）1 期
An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 22
- 主要终点
- Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male or female participants aged ≥18 years
- •Body weight > 40 kilograms (kg)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
- •Participants with advanced and/or metastatic solid tumors
- •Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
- •Negative serum pregnancy test
- •Participants must have adequate cardiovascular, hematological, liver and renal function.
排除标准
- •Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
- •Active second malignancy within 2 years prior to screening
- •History or current clinically significant cardiovascular/cerebrovascular disease
- •Active or history of autoimmune disease
- •Serious, uncontrolled infection
- •Known clinically significant liver disease
- •Unresolved acute toxicity > grade 1 from prior therapy
研究组 & 干预措施
Part I: RO7567132 Dose Escalation With or Without Atezolizumab
Experimental
干预措施: RO7567132 and Atezolizumab (Drug)
Part II: RO7567132 Backfill With Atezolizumab
Experimental
干预措施: RO7567132 and Atezolizumab (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
时间窗: Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)
时间窗: From baseline to 3 weeks on study
次要结局
- Time of Maximum Concentration (Tmax)(Up to a maximum of 24 months)
- Maximum Concentration (Cmax) Derived for RO7567132(Up to a maximum of 24 months)
- Minimum Concentration (Cmin)(Up to maximum of 24 Months)
- Clearance (CL) or Apparent Clearance (CL/F)(Up to a maximum of 24 months)
- Volume of Distribution at Steady State (Vss)(Up to a maximum of 24 months)
- Area Under the Curve (AUC) for Various Time Intervals(Up to a maximum of 24 months)
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132(Up to 24 months)
- Objective Response Rate (ORR)(Up to a maximum of 24 months)
- Disease Control Rate (DCR)(Up to a maximum of 24 months)
- Duration of Response (DoR)(Up to a maximum of 24 months)
- Progression Free Survival (PFS)(Up to a maximum of 24 months)
- Overall Survival (OS)(Up to a maximum of 24 months)
研究者
研究点 (22)
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