Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.
The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives
- To characterize the pharmacokinetic (PK) profiles of ADG106
- To evaluate the immunogenicity of ADG106
- To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Indiana
-
Lafayette、Indiana、美国、47905
- Horizon Oncology Research
-
-
Texas
-
San Antonio、Texas、美国、78229
- NEXT Oncology
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Male or female, 18 years of age or older at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.
Exclusion Criteria
- Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
- History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis).
- History of clinically significant cardiac disease.
- Uncontrolled current illness.
8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.
9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.
14. Subjects who got either below treatment:
- Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment.
- Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ADG106 剂量递增
|
IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of participants experiencing dose-limiting toxicities
大体时间：2 Cycles (42 days)
|
2 Cycles (42 days)
|
|
Number of participants experiencing clinical and laboratory adverse events (AEs)
大体时间：First dose to 28 days post last dose
|
First dose to 28 days post last dose
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The area under the curve (AUC) of plasma concentration of drug
大体时间：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
|
Maximum concentration (Cmax)
大体时间：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
|
Time at which maximum concentration (Tmax)
大体时间：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
|
Lowest plasma concentration (C[trough])
大体时间：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ADG106的临床试验
-
National University Hospital, SingaporeMerck Sharp & Dohme LLC; Adagene Inc招聘中
-
National University Hospital, SingaporeBristol-Myers Squibb; Adagene Inc; Singapore Translational Cancer Consortium招聘中
-
National University Hospital, SingaporeAdagene Inc招聘中