Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer

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追踪信息

首次提交日期 ^ICMJE

September 4, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 20, 2018

预计主要完成日期

May 10, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Incidence and severity of dose limiting toxicities (DLTs)[ Time Frame: 21 days ]

The time frame will expand to 42 days for the second part of the study

Number of participants with Adverse Events[ Time Frame: 2.5 years ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Concentration versus time profiles for NJH395 and its catabolite[ Time Frame: 126 days ]
PK parameter (Cmax) for NJH395[ Time Frame: 126 days ]
Pharmacokinetic (PK) parameter (AUC) for NJH395[ Time Frame: 126 days ]
Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab[ Time Frame: 126 days ]
Overall Response Rate[ Time Frame: 2.5 years ]
Response assessed by RECIST v1.1 and iRECIST
Clinical Benefit Rate (CBR)[ Time Frame: 2.5 years ]
Response assessed by RECIST v1.1 and iRECIST
Progression Free Survival (PFS)[ Time Frame: 2.5 years ]
Time from start of treatment to date of the first documented progression or death in months
Duration of Response (DOR)[ Time Frame: 2.5 years ]
Response assessed by RECIST v1.1 and iRECIST
Characterization of tumor-infiltrating lymphocytes by IHC[ Time Frame: Cycle 1 Day 5, Cycle 2 Day 1 (each cycle is 21 days), Cycle 8 Day 1 and at end of treatment (expected between months 6 and 7) ]
Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8).

描述性信息

简略标题 ^ICMJE

Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer

正式标题 ^ICMJE

A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies

简要概况

A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies

详细说明

This study has two parts. There will be a single dose of NJH395 in the first part and multiple doses of NJH395 in the second part. After the first part is completed, the second part may open.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: NJH395
Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent

研究工具

Experimental: NJH395
Includes non-breast HER2-positive advanced malignancies

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 10, 2021

预计主要完成日期

May 10, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Key Inclusion Criteria: - Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer - Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 who have progressed or are intolerant to all approved therapies known to confer clinical benefit. - Eastern Cooperative Oncology Group (ECOG) performance status ≤2. - Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy prior to therapy, and during therapy on this study. Key Exclusion Criteria: - History of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody. - Patients previously treated with TLR 7/8 agonist. - Impaired cardiac function or history of clinically significant cardiac disease - Active, known or suspected autoimmune disease. - Human Immunodeficiency virus (HIV) infection - History of or current interstitial lung disease or pneumonitis Grade 2 or greater. - Discontinued prior checkpoint inhibitor due to a checkpoint inhibitor related toxicity. - Currently receiving medications known to cause Torsades de Pointe that cannot be discontinued 7 days prior to starting treatment Other protocol defined inclusion/exclusion criteria may apply.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Novartis Pharmaceuticals

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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