NCT06679985进行中（未招募）2 期
A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 83
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
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
- •Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants.
- •Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (PD) after surgical and/or locoregional therapies.
- •≥ 1 measurable lesion (per RECIST v1.1) that is untreated.
排除标准
- •Has received prior systemic therapy for HCC.
- •Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.
- •Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Has moderate or severe ascites.
- •Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- •Additional protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
Experimental
干预措施: Casdozokitug (Drug)
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
Experimental
干预措施: Toripalimab (Drug)
Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
Experimental
干预措施: Toripalimab (Drug)
Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
Experimental
干预措施: Casdozokitug (Drug)
Arm C: Toripalimab + Bevacizumab
Active Comparator
干预措施: Toripalimab (Drug)
Arm C: Toripalimab + Bevacizumab
Active Comparator
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to approximately 2 years
次要结局
- ORR by Investigator Review According to HCC Modified RECIST (mRECIST)(Up to approximately 2 years)
- Duration of Response (DoR) by Investigator Review According to RECIST v1.1(Up to approximately 2 years)
- DoR by Investigator Review According to HCC mRECIST(Up to approximately 2 years)
- Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1(Up to approximately 2 years)
- PFS by Investigator Review According to HCC mRECIST(Up to approximately 2 years)
- Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1(Up to approximately 2 years)
- DCR by Investigator Review According to HCC mRECIST(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Maximum Concentration (Cmax)(Up to approximately 25 months)
- Minimum Concentration (Cmin)(Up to approximately 25 months)
- Time to Cmax (Tmax)(Up to approximately 25 months)
研究者
研究点 (83)
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