NCT05905614已完成1 期
An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose（MTD）
研究概览
简要总结
This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced solid tumors；
- •ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
- •Life expectancy ≥ 3 months；
- •Good organ function；
- •According to the investigator's judgment, the patient could comply with the trial protocol;
- •Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
排除标准
- •Received other antineoplastic therapy before the first dose；
- •Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
- •Enroll in other clinical trials and receive treatment as a subject before initial medication;
- •Patients with allergic constitution or history of severe allergy;
- •Hepatitis B surface antigen [HBsAg] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency;
- •Cardiac criteria: presence of factors that may cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, and other concomitant medications known to prolong the QT interval. The presence of any unstable cardiovascular disease;
- •Hypertension that cannot be effectively controlled after treatment;
- •Have severe lung disease;
- •Pregnant and lactating women;
- •Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
- •Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
- •Had a definite history of neurological or mental disorders;
- •Other circumstances considered by the investigator to be inappropriate for participation in the study.
研究组 & 干预措施
SPH4336 Tablets
Experimental
SPH4336 Tablets
干预措施: SPH4336 Tablets (Drug)
结局指标
主要结局
Maximum tolerated dose（MTD）
时间窗: Up to 28 days
Measurement of MTD of SPH4336 in all subjects
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days
Measurement of DLT of SPH4336 in all subjects
次要结局
- Objective response rate (ORR)(Up to 1 year)
- Progression-free survival (PFS)(Up to 1 year)
- Cmax(predose,1,2,4,5,6,8,10,12,24 hours post-dose)
- Tmax(predose,1,2,4,5,6,8,10,12,24 hours post-dose)
- Disease control rate (DCR)(Up to 1 year)
- Duration of remission (DOR)(Up to 1 year)
- Safety and tolerability(Up to 1 year)
研究者
研究点 (4)
Loading locations...
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