NCT03696771已完成1 期
A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
详细描述
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
- •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 ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
NJH395
Experimental
Includes non-breast HER2-positive advanced malignancies
干预措施: NJH395 (Drug)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: 2.5 years
Incidence and severity of dose limiting toxicities (DLTs)
时间窗: 21 days
The time frame will expand to 42 days for the second part of the study
次要结局
- Concentration versus time profiles for NJH395 and its catabolite(126 days)
- Duration of Response (DOR)(2.5 years)
- Overall Response Rate(2.5 years)
- PK parameter (Cmax) for NJH395(126 days)
- Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab(126 days)
- Pharmacokinetic (PK) parameter (AUC) for NJH395(126 days)
- Clinical Benefit Rate (CBR)(2.5 years)
- Progression Free Survival (PFS)(2.5 years)
- Characterization of tumor-infiltrating lymphocytes by IHC(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))
研究者
研究点 (2)
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