NCT05215067已完成2 期
A Phase II Trial of AK104 in Combination With Docetaxel in Subjects With Advanced Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Treatment With One Prior Anti-PD-1/PD-L1 Monoclonal Antibody (mAb)
Akeso1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年5月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody
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
- •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
- •Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
- •Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
- •No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
- •Has at least 1 measurable lesion per 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.
- •Has received treatment with docetaxel.
- •History of severe bleeding tendency or coagulation disorder.
研究组 & 干预措施
AK104 plus Docetaxel
Experimental
AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity.
干预措施: AK104 (Drug)
AK104 plus Docetaxel
Experimental
AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 2 years
次要结局
- Number of patients with Adverse Events (AEs)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Progression free survival (PFS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Antidrug antibodies (ADA) of AK104(Up to approximately 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant TumorsAdvanced Malignant TumorsNCT05235542Akeso128
终止
1 期
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell LymphomaPeripheral T-cell LymphomaNCT04444141Akeso6
已完成
1 期
Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid TumorsAdvanced Solid TumorsMelanomaNCT04172454Akeso68
已完成
2 期
AK104 in Neoadjuvant Treatment of Cervical CancerCervical CancerNCT05227651Akeso14
招募中
2 期
Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal CancerLocally Advanced Rectal CancerNCT05980689Sun Yat-sen University33