NCT03652077已完成1 期
A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select 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
- 40
- 试验地点
- 4
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
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
- •Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).
- •Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
- •Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).
- •Eastern Cooperative Oncology Group performance status 0 or
- •Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
排除标准
- •Laboratory values at screening outside the protocol-defined ranges.
- •Administration of colony-stimulating factors within 14 days before Study Day
- •Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- •Receipt of a live vaccine within 30 days of planned start of study drug.
- •Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.
- •Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
- •Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- •Active infection requiring systemic therapy.
- •Evidence of active HBV or HCV infection.
- •Known history of HIV (HIV 1/2 antibodies).
- •Known allergy or reaction to any component of study drug or formulation components.
- •Prior treatment with an anti-TIM-3 antibody for any indication.
研究组 & 干预措施
INCAGN02390
Experimental
干预措施: INCAGN02390 (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Up to 12 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
时间窗: Up to approximately 1 month
PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
次要结局
- Tmax of INCAGN02390(Up to 12 months)
- Cmax of INCAGN02390(Up to 12 months)
- Cmin of INCAGN02390(Up to 12 months)
- AUC0-t of INCAGN02390(Up to 12 months)
- Objective response rate(Up to 12 months)
- Duration of response(Up to 12 months)
- Disease control rate(Up to 12 months)
- Progression-free survival(Up to 12 months)
- Level of binding of INCAGN02390 to TIM-3(Up to approximately 3 months)
- Immunogenicity of INCAGN02390(Up to 12 months)
研究者
研究点 (4)
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