A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HS387 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Dose-limiting Toxicities Incidence Count Among Study Participant
研究概览
简要总结
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)
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 must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Men or women ≥18 years old and ≤75 years old.
- •Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
- •Survival expectation is ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Phase Ⅰa: Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.
- •Phase Ⅰb: Subjects with advanced solid tumors have at least one measurable lesion according to RECIST 1.
- •Subjects with adequate organ function at the time of screening.
- •Serum pregnancy test (for female of childbearing potential) negative prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months after the last dose of the investigational product.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
- •Has active infection.
- •Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
- •Significant impairment of oral drug absorption.
- •Has interstitial lung disease.
- •Pregnant or lactating women.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Has a major surgical procedure within 4 weeks prior to the first administration.
- •Has a treatment history of KIF18A inhibitor.
- •In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.
研究组 & 干预措施
HS387 group
干预措施: HS387 (Drug)
结局指标
主要结局
Dose-limiting Toxicities Incidence Count Among Study Participant
时间窗: 2 years
DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.
Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: 2 years
Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0
次要结局
未报告次要终点