A Phase Ib/II Study of AK112（PD-1 / VEGF Bispecific Antibody） in Combination With AK117（Anti-CD47 Antibody）With or Without Chemotherapy in Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Number of patients with Adverse Events (AEs)
研究概览
简要总结
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old.
- •Have a life expectancy of at least 3 months.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
- •cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.
- •cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer.
- •cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma.
- •cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following.
- •Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- •Has adequate organ function.
排除标准
- •Undergone major surgery within 30 days prior to the first dose of study treatment.
- •Active central nervous system (CNS) metastases.
- •History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- •Active Hepatitis B or Hepatitis C.
- •Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
- •History of severe bleeding tendency or coagulation disorder.
研究组 & 干预措施
Phase II
AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
干预措施: Chemotherapy (Drug)
Phase II
AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
干预措施: AK117 (Drug)
Phase Ib
Subjects receive AK112 plus AK117 until progression
干预措施: AK112 (Drug)
Phase Ib
Subjects receive AK112 plus AK117 until progression
干预措施: AK117 (Drug)
Phase II
AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
干预措施: AK112 (Drug)
结局指标
主要结局
Number of patients with Adverse Events (AEs)
时间窗: Up to approximately 2 years
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Objective Response Rate (ORR)
时间窗: Up to approximately 2 years
次要结局
- Disease control rate (DCR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Progression free survival (PFS)(Up to approximately 2 years)