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A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors (GW01-200-01)

2026年8月12日 更新者：Groovy Medicine (Hangzhou) Ltd.

A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors

A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

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 Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Peking University Cancer Hospital
        • 接触：
        • 首席研究员：
          • Zhi-Hao Lu, M.D.
    • Heibei
      • Langfang、Heibei、中国、065000
        • 招聘中
        • Hebei Cancer Hospital of Chinese Academy of Medical Sciences
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • 招聘中
        • Zhejiang Cancer Hospital
        • 接触：
        • 首席研究员：
          • Zheng-Bo Song, M.D.

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:

  • Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
  • Have at least one measurable target lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum life expectancy ≥ 3 months.
  • Adequate organ and marrow function.

Exclusion Criteria:

  • Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
  • History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
  • Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
  • Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
  • Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
  • Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.
  • Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
  • Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
  • Known history of infection with human immunodeficiency virus (HIV).
  • Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
  • For female subjects: currently pregnant or lactating.
  • Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
  • Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
  • Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.

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：Ia-Part A
Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
药品：GW01-200
GW01-200 tablets will be administered orally.
实验性的：Ia-Part B
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
药品：GW01-200
GW01-200 tablets will be administered orally.
实验性的：Ib-Part C
Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
药品：GW01-200
GW01-200 tablets will be administered orally.
实验性的：Ib-Part D
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.
药品：GW01-200
GW01-200 tablets will be administered orally.

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
Number of participants with adverse events (AEs) and serious AEs (SAEs)
大体时间：Up to approximately 2 years
To assess the safety and tolerability of GW01-200 tablets.
Up to approximately 2 years
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
大体时间：At the end of Cycle 1 (each cycle is 28 days)
Number of participants with dose-limiting toxicities (DLTs)
At the end of Cycle 1 (each cycle is 28 days)
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
大体时间：Up to approximately 2 years
Objective response rate (ORR) assessed by investigator.
Up to approximately 2 years
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
大体时间：Up to approximately 2 years
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.
Up to approximately 2 years

次要结果测量

结果测量
措施说明
大体时间
Maximum concentration (Cmax)
大体时间：Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Area under the concentration-time curve (AUC)
大体时间：Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Time to maximum concentration (Tmax)
大体时间：Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Elimination half-life (t1/2)
大体时间：Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
Up to approximately 2 years
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
大体时间：Up to approximately 2 years
ORR assessed by investigator.
Up to approximately 2 years
Duration of response (DoR)
大体时间：Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to approximately 2 years
Disease control rate (DCR)
大体时间：Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to approximately 2 years
Progression-free survival (PFS)
大体时间：Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to 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。

赞助

Groovy Medicine (Hangzhou) 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 (实际的)

2026年7月17日

初级完成 (估计的)

2029年1月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • GW01-200-01

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

是的

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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