NCT07446816招募中1 期
A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy indicators
研究概览
简要总结
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily signed a written informed consent form before the start of the study;
- •Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
- •Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
- •At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) [Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included].
- •Subjects with ECOG PS score of 0-1;
- •Subjects with expected survival more than 3 months;
- •Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study;
排除标准
- •Women during pregnancy or breastfeeding;
- •HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;
- •Having received drug treatment from another clinical trial within the four weeks prior to enrolment;
- •Aallergy to the active ingredient or excipients of the investigational medicinal product;
- •Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
- •The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
研究组 & 干预措施
Experimental group
Experimental
Intravenous infusion, Once per treatment cycle
干预措施: Hemay181 (Drug)
结局指标
主要结局
Efficacy indicators
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate (ORR)
次要结局
- Safety indicators(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
研究点 (1)
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