A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 40
- 主要终点
- Number of Participants with Dose-limiting Toxicity (DLTs)
研究概览
简要总结
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Life expectancy >=3 months, in the investigator's judgment
- •Adequate hematologic and end-organ function
- •Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
- •Measurable disease per RECIST v1.1
- •Tumor specimen availability, for certain cohorts
排除标准
- •Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions
- •Active hepatitis B or C
- •Active tuberculosis
- •Positive test for human immunodeficiency virus (HIV) infection
- •Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •Active or history of autoimmune disease
- •Prior allogeneic stem cell or organ transplantation
- •Uncontrolled tumor-related pain
- •Significant cardiovascular disease
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Dose Escalation Cohort
Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
干预措施: RO7566802 (Drug)
Dose Expansion Cohort
Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
干预措施: RO7566802 (Drug)
Dose Escalation Cohort
Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
干预措施: Atezolizumab (Drug)
Dose Expansion Cohort
Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicity (DLTs)
时间窗: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
时间窗: Up to approximately 4 years
次要结局
- Area Under the Serum Concentration Time Curve (AUC) of RO7566802(Up to approximately 4 years)
- Maximum Serum Concentration (Cmax) of RO7566802(Up to approximately 4 years)
- Volume of Distribution at Steady State (Vss) of RO7566802(Up to approximately 4 years)
- Minimum Serum Concentration (Cmin) of RO7566802(Up to approximately 4 years)
- Serum Concentration of Atezolizumab(Up to approximately 4 years)
- Total Clearance (CL) of RO7566802(Up to approximately 4 years)
- Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)(Up to approximately 4 years)
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802(From Baseline up to approximately 4 years)