NCT04547101终止2 期
A Single-arm, Open-label, Multicenter, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年4月24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
- 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
It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed written informed consent form voluntarily.
- •Male or female, age ≥ 18 years on the day of signing informed consent form.
- •ECOG of 0 or
- •Estimated life expectancy of ≥3 months.
- •Histologically or cytologically documented locally advanced unresectable or metastatic solid tumors.
- •Confirmed MSI-H/dMMR status by the central laboratory.
- •Have experienced documented disease progression during or after at least first-line therapy.
- •Have radiologically measurable disease based on RECIST 1.
- •Adequate organ function.
- •Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
排除标准
- •Prior use of investigational products or devices within 4 weeks prior to C1D1 (Cycle 1 Day 1, the first dose of study drug).
- •Presence of active autoimmune disease that have received systematic treatment in the past 2 years; or that is judged to be possibly relapsed or requires planned treatment by investigators.
- •Active inflammatory bowel disease or that required treatment (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
- •Prior use of systematic corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to C1D
- •Prior exposure to tumor immunotherapy, such as checkpoint inhibitors (eg. anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody), checkpoint agonists or cellular therapy.
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Known presence or history of interstitial lung disease.
- •History of gastrointestinal perforation and/or fistula within 6 months prior to C1D
- •Serious infections within 4 weeks prior to C1D
- •Known presence of active tuberculosis.
- •Known untreated chronic hepatitis B or chronic hepatitis B virus DNA exceeding 1000 IU/ mL or active hepatitis C virus.
- •Receipt of recent radiotherapy or anti-tumor treatment within 4 weeks prior to C1D
- •Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease or central nervous system metastasis, with some exceptions.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria. Hair loss is excluded
- •Known history of sever hypersensitivity reaction to other monoclonal antibodies.
- •Known history of allergy or hypersensitivity to AK104 or any of its components.
- •Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.
研究组 & 干预措施
AK104
Experimental
干预措施: AK104 (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
- Disease control rate (DCR)(Up to 2 years)
- Observed pharmacokinetics (PK) exposure of AK104(From first dose of AK104 through to 90 days after last dose of AK104)
- Progression-free survival (PFS)(Up to 2 years)
- Adverse events (AEs)(From first dose of AK104 through to 90 days after last dose of AK104)
- Duration of response (DoR)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK104 through to 90 days after last dose of AK104)
研究者
研究点 (1)
Loading locations...
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