A Phase Ib, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 13
- 主要终点
- Percentage of Participants with Adverse Events (AEs)
研究概览
简要总结
CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
干预措施: Obinutuzumab (Drug)
Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
干预措施: Atezolizumab (Drug)
Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
干预措施: Cibisatamab (Drug)
Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to 5 years
Confirmed Objective Response Rate (ORR)
时间窗: Baseline up to 5 years
次要结局
- Confirmed ORR, as Determined by an Independent Review Facility (IRF) According to Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1)(Up to 5 years)
- Duration of Response (DOR)(From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years))
- Disease Control Rate (DCR)(Up to 5 years)
- Progression Free Survival (PFS)(From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 5 years))
- Overall Survival (OS)(From enrollment to death from any cause (up to 5 years))
- Total Clearance (CL) for Cibisatamab(At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years))
- Volume of Distribution at Steady State (Vss) of Cibisatamab(At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years))
- Area Under the Concentration-Time Curve (AUC0-t) for Cibisatamab(At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years))
- Maximum Serum Concentration (Cmax) of Cibisatamab(At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years))
- CL of Atezolizumab(At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days))
- Vss of Atezolizumab(At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days))
- AUC0-t of Atezolizumab(At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days))
- Cmax of Atezolizumab(At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days))
- CL of Obinutuzumab(At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days))
- Vss of Obinutuzumab(At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days))
- AUC0-t of Obinutuzumab(At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days))
- Cmax of Obinutuzumab(At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days))
- Incidence of Anti-Drug Antibodies (ADAs) to Cibisatamab(Baseline up to 5 years)
- Incidence of ADAs to Atezolizumab(Baseline up to 5 years)
- Incidence of ADAs to Obinutuzumab(Baseline up to 5 years)