NCT04444167已完成1 期
An Open-Label Multi-Center Phase Ib/II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in Combination With Lenvatinib As the First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma
Akeso1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年7月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.
详细描述
This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.
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
- •Signed written informed consent form voluntarily.
- •Histologically or cytologically documented hepatocellular carcinoma.
- •BCLC stage C, and non-resectable BCLC stage B .
- •At least one measurable lesion according to RECIST criteria.
- •ECOG of 0 or
- •Adequate organ function.
- •Estimated life expectancy of ≥3 months.
- •For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.
排除标准
- •Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- •History of hepatic encephalopathy or liver transplantation.
- •Clinical significance of hydrothorax, ascites or pericardial effusion.
- •Central nervous system metastases and/or carcinomatous meningitis.
- •Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
- •Occurred arteriovenous thromboembolic events within 6 months before the first administration.
- •Tumor volume > 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
- •Inadequately controlled arterial hypertension.
- •Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long QT syndrome.
- •Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
- •Severe infections.
- •Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- •Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
- •Unable to receive an enhanced CT or MRI scan of the liver.
研究组 & 干预措施
AK104 and Lenvatinib
Experimental
AK104 6 mg/kg IV every 2 weeks (Q2W) Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD
干预措施: AK104 (Biological)
AK104 and Lenvatinib
Experimental
AK104 6 mg/kg IV every 2 weeks (Q2W) Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
次要结局
- Progression-free survival (PFS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose of AK104 and)
- Observed concentrations of AK104(From first dose of AK104 through 90 days after last dose of AK104)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK104 through 90 days after last dose of AK104)
研究者
研究点 (1)
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