A Study of HS-10587 in Patients With Advanced Solid Tumors
2026年4月28日 更新者:Jiangsu Hansoh Pharmaceutical Co., Ltd.
An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors
This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.
研究概览
研究类型
介入性
注册 (估计的)
362
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
- Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.
- Evidence of MTAP deletion in the tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.
Exclusion Criteria:
- History of other primary malignancies.
- Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
- Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
- Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Severe, uncontrolled, or active cardiovascular diseases.
- Severe or poorly controlled diabetes.
- Severe or poorly controlled hypertension.
- Severe infection within 4 weeks prior to the first dose.
- Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
- Known active infectious diseases.
- Clinically significant gastrointestinal dysfunction.
- Moderate to severe pulmonary diseases that seriously affect respiratory function.
- Prior history of severe neurological or mental disorders.
- Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
- History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.
- Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
|
HS-10587 tablet
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of DLT
大体时间:Up to 21 days after the first administration. (first cycle)
|
dose-limiting toxicities
|
Up to 21 days after the first administration. (first cycle)
|
|
MTD or MAD
大体时间:Up to 21 days after the first administration. (first cycle)
|
maximum tolerated dose (MTD) or maximum applicable dose (MAD)
|
Up to 21 days after the first administration. (first cycle)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
大体时间:From time of informed consent to 28 days post last dose of HS-10587.
|
Number of participants with AEs and SAEs
|
From time of informed consent to 28 days post last dose of HS-10587.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
大体时间:Predose and postdose up to end of treatment, approximately 2 years
|
Maximum concentration (Cmax).
|
Predose and postdose up to end of treatment, approximately 2 years
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
大体时间:Predose and postdose up to end of treatment, approximately 2 years.
|
Time of maximum concentration (Tmax).
|
Predose and postdose up to end of treatment, approximately 2 years.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
大体时间:Predose and postdose up to end of treatment, approximately 2 years.
|
area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)
|
Predose and postdose up to end of treatment, approximately 2 years.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
大体时间:Predose and postdose up to end of treatment, approximately 2 years
|
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
|
Predose and postdose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors
大体时间:Predose and post dose up to end of treatment, approximately 2 years
|
Objective response rate (ORR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
大体时间:Predose and post dose up to end of treatment, approximately 2 years.
|
Duration of response (DOR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
大体时间:Predose and post dose up to end of treatment, approximately 2 years
|
Disease control rate (DCR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
大体时间:Predose and post dose up to end of treatment, approximately 2 years.
|
Time to response (TTR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
大体时间:Predose and post dose up to end of treatment, approximately 2 years.
|
Progression-free survival (PFS) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
大体时间:Predose and post dose up to end of treatment, approximately 2 years
|
Overall survival (OS) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月4日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年4月20日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年4月28日
最后验证
2026年4月1日
更多信息
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