NCT07687914尚未招募2 期
Phase II Clinical Study of IMM2510 for Injection Combined With IMM27M for Injection in Advanced Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Phase 2, open-label, multicenter,study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant - Page 1 of 5 - protein) combine with IMM27M(Anti-CTLA-4 Humanized monoclonal antibody) in patients with advanced hepatocellular carcinoma who not have received the treatment for aHCC in past
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- •Age greater than or equal to 18 years old and ≤ 75 years old at the same time of signing the informed consent.
- •Histologically or cytologically confirmed for HCC
- •Eastern Cooperative Oncology Group (ECOG) 0 to
- •Adequate organ function as defined in protocol.
排除标准
- •History of other malignancy within the past 5 years with exceptions.
- •Systemic chemotherapy was administered within 4 weeks prior to the first administration.
- •Activated symptomatic brain metastases and leptomeningeal disease.
- •History of hepatic encephalopathy disease in past 12 months.
- •Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment. Participant has known active infection requiring parenteral antibiotic treatment.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years
次要结局
- Maximum Plasma Concentration [Cmax](through study completion, an average of 1 year)
- Area Under the Curve from time 0 to time t（AUC0-t）(through study completion, an average of 1 year)
- Disease Control Rate(DCR)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years)
- Duration of Response (DOR)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years)
- Progression- Free Survival(PFS)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- Overall Survival(OS)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)(From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment)
研究者
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