NCT04262739Unknown1 期
Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors Who Have Failed Approved Standard Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Safety assessment: Adverse event
研究概览
简要总结
The objectives of this study are:
Part 1:
- To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies.
- To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P.
Part 2:
- To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies
- To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19+ years old
- •Diagnosed with advanced solid tumor histologically/cytologically
- •Patient without standard therapies or who have failed approved standard therapies
- •Those with a disease that is measurable and/or evaluable with the appropriate imaging examination according to RECIST v1.1
- •ECOG performance status 0 to 2
- •Patients with the suitable marrow, kidney, liver functions, blood coagulation and glycemic control functions
- •Patients whose Life expectancy is over 12 weeks
- •Patients who signed the agreement to voluntarily participate in this study
排除标准
- •Patients who have received a major surgery, radiotherapy, chemotherapy, biologic therapy, targeted therapy, cancer immunotherapy or metabolic therapy within specified weeks counting from the initial administration of the IPs
- •Diagnosed with a malignant tumor other than the relevant disease in the last 5 years from the initial administration of the IPs
- •Toxicity level has not been recovered to CTCAE Grade 1 or lower
- •Has uncontrolled metastasis to the CNS
- •Suspected of having a serious infectious disease, paralysis of intestine, bowel obstruction, interstitial pneumonia or pulmonary fibrosis
- •Had serious GI bleed or a disease that may affect the absorption of the oral drug in the past 4 weeks
- •Considered as having a serious heart disease by the investigator or a serious internal disease
- •Has administered a drug from another study within 4 weeks
- •Has administered live vaccines within 4 weeks
- •Has abused substance or alcohol within 12 weeks
- •Has a serious trauma
- •Has a history or currently has a type 1 or 2 diabetes
- •Has a history of lactic acidosis
- •Has glucose-6-phosphate dehydrogenase deficiency
- •Has HIV or active or an active hepatitis B or C
- •Has a history of psychological condition that could threaten observation of this protocol
- •Has a history of hypersensitive reaction to the main ingredient or component of the IP or biguanide class drugs
- •Being pregnant or a lactating woman, or (+) pregnancy test
- •A female subject of a childbearing age who plans to get pregnant or disagrees to use recommended contraceptions
- •Has not agreed to abstain from alcohol
- •Considered as unsuitable for the study for other reason by the investigator
研究组 & 干预措施
NYH817G
Experimental
干预措施: NYH817G (Drug)
NYH100P
Experimental
干预措施: NYH100P (Drug)
NYH817G and NYH100P
Experimental
干预措施: NYH817G and NYH100P (Drug)
结局指标
主要结局
Safety assessment: Adverse event
时间窗: Up to 2 years
Number of adverse events as assessed by NCI CTCAE v5.0
Effectiveness assessment: Disease control rate
时间窗: Up to 2 years
To assess the clinical efficacy associated wtih the administration of NYH817G and NYH100P according to the RECIST v1.1
次要结局
- Pharmacokinetic (PK) Parameter: Cmax of NYH817G and NYH100P(At the start and end of Cycle 1 (each cycle is 21 days))
研究者
研究点 (1)
Loading locations...
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