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A Single-Arm, Open-Label Phase Ia/Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)

2026年6月1日 更新者：Foresight Therapeutics (Hefei) Co., Ltd.

This is a Phase Ia/Ib clinical study of FS-207, an investigational oral tablet, in patients with advanced solid tumors that are microsatellite instability-high, also called MSI-H. MSI-H tumors have specific changes in DNA repair pathways and may depend on the WRN protein to survive. FS-207 is designed to inhibit WRN.

The main purpose of this study is to evaluate the safety and tolerability of FS-207 and to understand how the drug moves through the body. The study will also look for early signs of anti-tumor activity.

This study has two parts. In the first part, called dose escalation, small groups of patients will receive increasing dose levels of FS-207 to help identify a safe and appropriate dose for further study. In the second part, called dose expansion, additional patients with selected MSI-H advanced solid tumors will receive FS-207 at dose level(s) chosen based on the earlier safety and clinical data.

Participants will take FS-207 orally once daily. Study doctors will monitor participants closely through physical examinations, blood and urine tests, electrocardiograms, heart function tests, imaging scans, and blood samples for pharmacokinetic testing. Tumor assessments will be performed regularly to evaluate whether the cancer has responded to treatment, remained stable, or progressed.

This is an open-label study, which means that both the participants and study doctors will know that FS-207 is being given. There is no placebo group in this study.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

156

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
      • Beijing、中国、100142
        • Peking University Cancer Hospital
        • 接触：
      • Shanghai、中国、200072
        • Shanghai Tenth People's Hospital
    • Anhui
      • Hefei、Anhui、中国
        • The First Affiliated Hospital of Anhui Medical University
    • Fujian
      • Fuzhou、Fujian、中国、350014
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou、Guangdong、中国、510080
        • Guangdong Provincial People's Hospital
    • Henan
      • Zhengzhou、Henan、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan、Hubei、中国、430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Hunan
      • Changsha、Hunan、中国、410013
        • Hunan Cancer Hospital
    • Jiangxi
      • Nanchang、Jiangxi、中国、330029
        • Jiangxi Cancer Hospital
    • Jilin
      • Changchun、Jilin、中国、130012
        • Jilin cancer hospital
    • Liaoning
      • Shenyang、Liaoning、中国、110001
        • The First Affiliated Hospital of China Medical University
    • Ningxia
      • Yinchuan、Ningxia、中国、750004
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan、Shandong、中国、250117
        • Cancer Hospital of Shandong First Medical School
      • Qingdao、Shandong、中国、266000
        • The Affiliated Hospital of Qingdao University
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital,Sichuan University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine

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:

  • 1) Male or female patients aged ≥18 years at the time of signing the Informed Consent Form; 2) Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, whose disease has progressed or who have experienced intolerable toxicity following prior standard therapy. Additionally, participants must meet the following criterion: they have previously received treatment with at least one immune checkpoint inhibitor (ICI), and this treatment was deemed a failure due to disease progression or was discontinued due to intolerable toxicity; 3) Participants must provide a test report confirming a positive MSI-H/dMMR status in their tumor tissue; 4) Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0-1; 5) Anticipated life expectancy of ≥3 months; 6) Presence of at least one measurable lesion (according to RECIST v1.1 criteria, a measurable lesion is defined as a non-lymph node lesion with a longest diameter of ≥10 mm, or a lymph node lesion with a short axis of ≥15 mm, as measured by CT or MRI); 7) Female or male participants of childbearing potential must agree not to conceive, donate ova, or donate sperm from the date of signing the Informed Consent Form until 3 months after the last treatment administered in the study; furthermore, during this period, they must agree to utilize effective contraception (including one or more non-pharmacological contraceptive methods) or safety measures; 9) Agrees to comply with all requirements and procedures of the clinical trial and voluntarily signs the Informed Consent Form.

Exclusion Criteria:

  • 1) Known diagnosis of Werner syndrome; 2) Prior treatment with any medication targeting Werner syndrome helicase (WRN); 3) Receipt of any anti-tumor therapy within 3 weeks or 5 half-lives (whichever is longer) prior to the first dose; 4) Patients with adverse events related to prior anti-tumor therapy that have not resolved to Grade ≤1 (according to NCI CTCAE v6.0), excluding toxicities deemed by the investigator to pose no safety risk-such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement therapy, mild rash, hyperpigmentation, etc.-with specific cases subject to the investigator's judgment; 5) Undergone, or scheduled to undergo during the study period, major surgery (excluding procedures for vascular access placement, or biopsies performed via laparoscopy, mediastinoscopy, or thoracoscopy) within 4 weeks prior to the first dose; or undergone radical radiotherapy (palliative radiotherapy within 2 weeks prior to the first dose); 6) Leptomeningeal metastases; central nervous system (CNS) metastases with clinical symptoms; or other evidence indicating that CNS metastases are not adequately controlled, as determined by the investigator to render the participant unsuitable for enrollment. 7) Patients with symptomatic and unstable pleural effusion, ascites, or pericardial effusion, as determined by the investigator (patients whose clinical symptoms stabilize following therapeutic drainage of pleural fluid, ascites, or pericardial fluid may be enrolled); 8) Patients with other severe or uncontrolled systemic diseases, as determined by the investigator, including but not limited to interstitial lung disease, non-infectious pneumonitis; uncontrolled diabetes, renal disease requiring dialysis, severe hepatic disease (Child-Pugh Class B or C), acute pancreatitis, etc.; 9) Patients with cardiovascular diseases of significant clinical relevance;

    10) Patients with dysphagia, or gastrointestinal dysfunction or disease that could significantly affect the absorption of FS-207 tablets (e.g., severe ulcerative disease, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, etc.); 11) Patients with active autoimmune disease requiring systemic treatment, or a history of autoimmune disease with a potential for recurrence; 12) Patients with active Hepatitis B; active Hepatitis C; or Human Immunodeficiency Virus (HIV) infection; 13) Patients who have received a live vaccine or attenuated live vaccine within 4 weeks prior to the first dose of study medication; administration of inactivated vaccines is permitted; 14) Patients who have received treatment with other investigational drugs not yet approved for marketing, or who have participated in clinical trials involving interventional medical devices, within 4 weeks prior to the first dose of study medication; 15) Patients with active pulmonary tuberculosis (TB) (patients suspected of having active TB must undergo further evaluation by an infectious disease specialist to establish a definitive diagnosis) or a history of active TB; 16) Patients with any active infection requiring systemic treatment occurring within 2 weeks prior to the first dose of study medication; 17) Participants with a known or suspected history of severe allergic reactions to any component of the investigational drug, or a history of uncontrolled allergic asthma; 18) Patients who have previously undergone organ transplantation or allogeneic hematopoietic stem cell transplantation; 19) History of substance abuse, or known medical, psychological, or social conditions-such as a history of alcoholism or drug abuse; 20) Women who are pregnant or breastfeeding, or women of childbearing potential who have a positive pregnancy test result during the screening period; 21) Any other conditions that the investigator deems render the participant unsuitable for participation in this trial.

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：非随机化
  • 介入模型：顺序分配
  • 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：Part 1A
FS-207 monotherapy dose escalation
药品：FS-207
FS-207 will be administered orally
实验性的：Part 1B
FS-207 monotherapy Dose expansion and optimization
药品：FS-207
FS-207 will be administered orally

研究衡量的是什么？

主要结果指标

结果测量
大体时间
发生剂量限制性毒性（DLT）的参与者人数
大体时间：最长21天
最长21天
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Up to 3 years
Up to 3 years

次要结果测量

结果测量
大体时间
根据RECIST v1.1标准的缓解持续时间（DOR）
大体时间：最长5年
最长5年
根据RECIST v1.1标准的疾病控制率（DCR）
大体时间：最多5年
最多5年
根据RECIST v1.1标准的无进展生存期（PFS）
大体时间：最长5年
最长5年
根据 RECIST v1.1 标准的总生存期 (OS)
大体时间：最多5年
最多5年
Maximum Serum Concentration (Cmax) of FS-207
大体时间：up to 60 days
up to 60 days
Minimum Serum Concentration (Cmin) of FS-207
大体时间：Up to 60 days
Up to 60 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of FS-207
大体时间：Up to 60 days
Up to 60 days
Time to Achieve Cmax (Tmax) of FS-207
大体时间：Up to 60 days
Up to 60 days
Confirmed Objective Response Rate(ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
大体时间：Up to 5 years
Up to 5 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。

赞助

Foresight Therapeutics (Hefei) Co., Ltd.

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5月15日

初级完成 (估计的)

2029年1月15日

研究完成 (估计的)

2029年5月15日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • ForesightTx

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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