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A Study of DXC016 in Patients With Advanced Solid Tumors.

2026年11月9日 更新者：Hangzhou DAC Biotechnology Co., Ltd.

A Phase I, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DXC016 in Participants With Advanced Solid Tumors.

The investigational product DXC016 is an antibody-drug conjugate (ADC) targeting c-Met. Preclinical studies have demonstrated definitive antitumor activity and a manageable safety profile. On this basis, this first-in-human trial will be conducted in participants with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of DXC016, with the aim of determining the recommended Phase II dose (RP2D) and identifying the population most likely to benefit, thereby informing subsequent clinical development.

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)

170

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
    • Guangdong
      • Guangzhou、Guangdong、中国、510050
        • Sun Yat-sen University Cancer Center
        • 接触：
          • Ruihua Xu, MD (Doctor of Medicine)
          • 电话号码：+086-020-87343468
          • 邮箱：xurh@sysucc.org.cn
    • Guangxi
      • Nanning、Guangxi、中国、530200
        • Guangxi Medical University Cancer Hospital
        • 接触：
          • Yongqiang Li, Master of Medicine
          • 电话号码：+086-0771-5331955
          • 邮箱：lyq702702@126.com
    • Jiangxi
      • Nanchang、Jiangxi、中国、330052
        • The First Affiliated Hospital of Nanchang University
        • 接触：
          • Yong Li, MD (Doctor of Medicine)
          • 电话号码：+086-0791-8631933
          • 邮箱：liyongcsco@qq.com
        • 接触：
    • Shanxi
      • Taiyuan、Shanxi、中国、030000
        • Shanxi Cancer Hospital
        • 接触：
          • Hongxia Lu, Master of Medicine
          • 电话号码：+086-0351-4881611
          • 邮箱：53473139@qq.com
        • 接触：
          • Wang Xin, MD (Doctor of Medicine)
          • 电话号码：+086-0351-4881611
          • 邮箱：WXCAMS@126.com
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • Zhejiang Cancer Hospital
        • 接触：
          • Ji Zhu, MD (Doctor of Medicine)
          • 电话号码：+086-0571-88122222
          • 邮箱：zhuji@zjcc.org.cn
      • Hangzhou、Zhejiang、中国、310016
        • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
        • 接触：
          • Haizhou Lou, MD (Doctor of Medicine)
          • 电话号码：+086-0571-86090073
          • 邮箱：louhz09@163.com

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients must be able to provide documented voluntary informed consent and be aged ≥ 18 years.
  2. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer, gastric adenocarcinoma / gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer, hepatocellular carcinoma, cholangiocarcinoma, or other solid tumors, who have experienced disease progression during standard therapy, are intolerant of standard therapy, or have no standard therapy available.
  3. Measurable disease defined by RECIST version 1.1.
  4. ECOG 0-1.
  5. Life expectancy ≥ 3 months.
  6. Must have adequate organ function.
  7. Female participants of childbearing potential (WOCBP) must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not donate ova or undergo oocyte retrieval for their own use. Male participants must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not cryopreserve or donate sperm.
  8. Additional inclusion criteria for the dose expansion phase must be met, including requirements regarding tumor-type-specific disease history, number of prior lines of therapy, etc.
  9. Able to provide a tumor tissue specimen.

Exclusion Criteria:

  1. Has a history of any other malignancy.
  2. Has active central nervous system (CNS) involvement.
  3. Has uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion).
  4. Has had an active autoimmune disease requiring systemic immunosuppressive therapy within 12 months prior to signing the informed consent form.
  5. Has an active infection or medical condition requiring systemic antibiotic therapy within 7 days prior to the first dose of the study drug.
  6. Known human immunodeficiency virus (HIV) infection.
  7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  8. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
  9. Currently has active, non-infectious interstitial lung disease (ILD)/pneumonitis requiring systemic corticosteroid treatment, etc..
  10. Toxicities related to prior antineoplastic therapy that have not resolved to ≤ Grade 1 or returned to baseline.
  11. Known allergy, hypersensitivity, or intolerance to DXC016 or any of its excipients.
  12. Has undergone major surgery within 30 days prior to the first dose of study treatment, or has not yet recovered from the surgery.
  13. Inadequate washout period from prior therapy prior to the first dose of the study drug.
  14. Prior treatment with c-Met-targeted therapies (including antibodies, ADCs, chimeric antigen receptor T-cell [CAR-T] therapy, and other agents), with the exception that prior treatment with c-Met-targeted tyrosine kinase inhibitors (TKIs) is permitted.
  15. Any disease, medical condition, organ system dysfunction, or social situation that, in the opinion of the investigator, may interfere with the participant's ability to sign the informed consent form, adversely affect the participant's ability to cooperate and participate in the study, or compromise the interpretation of study results.

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：队列B
药品：Cohort B: DXC016 dose expansion

Subcutaneous (SC) administration (QW, Q2W or Q3W)
实验性的：队列A
药品：Cohort A: DXC016 dose escalation

Subcutaneous (SC) administration (QW, Q2W or Q3W)

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 and severity of adverse events (AEs)
大体时间：From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment
Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
大体时间：Assess approximately 12 months

To determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DXC016
Assess approximately 12 months
Recommended Doses for phase 2 (RP2D)
大体时间：from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first

To determine the Recommended Doses for phase 2 (RP2D) of DXC016
from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first

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

Hangzhou DAC Biotechnology 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12月1日

初级完成 (估计的)

2030年12月1日

研究完成 (估计的)

2031年6月1日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月9日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • DXC016-001

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

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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