NCT04444141终止1 期
A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Relapsed or Refractory Peripheral T Cell Lymphoma
Akeso1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of AK104，an anti- PD-1 and CTLA-4 bispecific antibody, in subjects with relapsed or refractory peripheral T cell lymphoma. The subject will receive AK104 450mg Q2W until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or for a maximum of 24 months.
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
- •Patients with histologically or cytologically confirmed advanced Peripheral T-cell lymphoma.
- •Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatments.
- •Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 or
- •Adequate organ functions
- •Effective methods of contraception.
- •Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
排除标准
- •Patients diagnosed as adult T cell lymphoma / leukemia (ATLL).
- •Any prior exposure to PD-1/PD-L1、CTLA-4 targeting agents.
- •Previous allogeneic stem cell transplant within 3 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression.
- •Serious systemic infections or local infections during the 2 months before screening.
- •History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- •Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- •Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
- •Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Subjects who received immunomodulatory drugs in 4 weeks before screening, including thymosin, interferon and interleukin, et al.
- •Patients who received radiotherapy, chemotherapy, targeted therapy (except TKI), immunotherapy within 4 weeks before screening, and patients who received TKI drugs within 2 weeks before screening.
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
Objective response is defined as the proportion of subjects with confirmed CR or PR according to the Lugano 2014 classification for lymphoma, assessed by the investigator.
次要结局
- Progression-free survival (PFS)(Up to 2 years)
- Number of subjects experiencing adverse events (AEs)(From the time of informed consent signed through 90 days after the last dose of AK104)
- Duration of response (DoR)(Up to 2 years)
- Observed concentrations of AK104(From first dose of AK104 through 90 days after last dose of AK104)
- Disease control rate (DCR)(Up to 2 years)
- 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)
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
进行中（未招募）
2 期
AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal CancerMSI-H/dMMR Gastric Carcinoma and Colorectal CancerNCT04556253Peking University47
已完成
2 期
AK104 in Neoadjuvant Treatment of Cervical CancerCervical CancerNCT05227651Akeso14
已完成
2 期
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung CancerAdvanced Non-small Cell Lung CancerNCT05215067Akeso44
已完成
1 期
Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid TumorsAdvanced Solid TumorsMelanomaNCT04172454Akeso68