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LY4052031 在晚期或转移性尿路上皮癌或其他实体瘤受试者中的研究 (NEXUS-01)

2026年11月3日 更新者：Eli Lilly and Company

LY4052031（一种靶向 Nectin-4 的抗体药物偶联物）在患有晚期或转移性尿路上皮癌或其他实体瘤的受试者中进行的 1a/1b 期研究

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 as monotherapy or in combination with pembrolizumab at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.

研究类型

介入性

注册 (估计的)

460

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

  • 姓名：Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • 电话号码：1-317-615-4559
  • 邮箱：LillyTrials@Lilly.com

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100142
        • 招聘中
        • Beijing Cancer hospital
      • Guangzhou、中国、510060
        • 招聘中
        • Sun Yat-sen University Cancer Center
      • Shanghai、中国、200000
        • 招聘中
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • 日本
      • Chūōku、日本、104-0045
        • 招聘中
        • National Cancer Center Hospital
      • Kashiwa, Chiba、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East
      • Kōtō City、日本、135-8550
        • 招聘中
        • The Cancer Institute Hospital of JFCR
      • Nagoya、日本、464-8681
        • 招聘中
        • Aichi Cancer Center Hospital
  • 法国
      • Villejuif、法国、94805
        • 招聘中
        • Institut Gustave Roussy (Igr)
  • 澳大利亚
      • Darlinghurst、澳大利亚、2010
        • 招聘中
        • St Vincent's Hospital
      • Nedlands、澳大利亚、6009
        • 招聘中
        • Linear Clinical Research
  • 美国
    • California
      • Duarte、California、美国、91010-0269
        • 招聘中
        • City of Hope National Medical Center
      • La Jolla、California、美国、92093
        • 招聘中
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Los Angeles、California、美国、90024
        • 招聘中
        • UCLA Department of Medicine-Hematology/Oncology
    • Colorado
      • Denver、Colorado、美国、80218
        • 招聘中
        • Sarah Cannon Research Institute at HealthOne
    • Florida
      • St. Petersburg、Florida、美国、33705
        • 完全的
        • Florida Cancer Specialists and Research Institute
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60637
        • 招聘中
        • University of Chicago Hospital
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 尚未招聘
        • IU Simon Cancer Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids、Michigan、美国、49546
        • 招聘中
        • START Midwest Cancer and Hematology Centers of W Michigan
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School of Medicine in St. Louis
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10029-6574
        • 招聘中
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
      • New York、New York、美国、10032-3729
        • 招聘中
        • Columbia University Irving Medical Center
      • New York、New York、美国、10016
        • 尚未招聘
        • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
    • Ohio
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • University Hospitals Cleveland Medical Center
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Sarah Cannon Research Institute
      • Nashville、Tennessee、美国、37203
        • 尚未招聘
        • Tennessee Oncology PLLC
    • Texas
      • Houston、Texas、美国、77030-4000
        • 招聘中
        • University of Texas MD Anderson Cancer Center
      • San Antonio、Texas、美国、78229
        • 招聘中
        • South Texas Accelerated Research Therapeutics (START)
    • Utah
      • Salt Lake City、Utah、美国、84112
        • 招聘中
        • University of Utah - Huntsman Cancer Institute
      • West Valley City、Utah、美国、84119
        • 招聘中
        • START Mountain Region
  • 英国
      • London、英国、EC1A 7BE
        • 招聘中
        • St Bartholomew's Hospital
      • Manchester、英国、M20 4BX
        • 招聘中
        • The Christie NHS Foundation Trust
  • 西班牙
      • Barcelona、西班牙、8908
        • 招聘中
        • Catalan Institute of Oncology Duran i Reynals Hospital
      • Madrid、西班牙、28041
        • 招聘中
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28050
        • 招聘中
        • Hospital Madrid Norte Sanchinarro
      • Seville、西班牙、41013
        • 招聘中
        • Hospital Universitario Virgen Del Rocio
  • 韩国
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center

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:

  • Have one of the following solid tumor cancers:

    • Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
    • Cohort A2/B/D: urothelial carcinoma
    • Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer

  • Prior Systemic Therapy Criteria:

    • Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
    • Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
    • Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer.

  • Prior enfortumab vedotin specific requirements:

    • Cohorts A1/A2/C/D: prior treatment with enfortumab vedotin is allowed, but not required
    • Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
    • Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.

  • Measurability of disease

    • Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
    • Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

  • Individual with known or suspected uncontrolled CNS metastases
  • Individual with uncontrolled hypercalcemia
  • Individual with uncontrolled diabetes
  • Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Recent thromboembolic event and/or clinically significant bleeding disorder
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • History of pneumonitis/interstitial lung disease
  • History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

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：并行分配
  • 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：LY4052031 (Dose-escalation, Cohort A1)

Escalating doses of LY4052031 administered intravenously (IV).
药品：LY4052031

Intravenous
实验性的：LY4052031 (Dose-optimization, Cohort A2)

Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
药品：LY4052031

Intravenous
实验性的：LY4052031 (Dose-expansion, Cohort B1, B2, C1)

LY4052031 administered IV.
药品：LY4052031

Intravenous
实验性的：LY4052031+ Pembrolizumab (Dose-expansion, Cohort D)

LY4052031 administered IV. Pembrolizumab administered IV.
药品：LY4052031

Intravenous

药品：Pembrolizumab

Intravenous

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
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
大体时间：Cycle 1 (21 Days)

Number of participants with dose-limiting toxicities (DLTs)
Cycle 1 (21 Days)
Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: Overall response rate (ORR)
大体时间：Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to Approximately 48 Months or 4 Years

次要结果测量

结果测量
措施说明
大体时间
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
大体时间：Cycle 1 (21 Days)

PK: Cmin of LY4052031
Cycle 1 (21 Days)
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
大体时间：Cycle 1 (21 Days)

PK: AUC of LY4052031
Cycle 1 (21 Days)
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Overall response rate (ORR)
大体时间：Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1))
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Duration of response (DOR)
大体时间：Up to Approximately 48 Months or 4 Years

DOR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Time to response (TTR)
大体时间：Up to Approximately 48 Months or 4 Years

TTR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Progression free survival (PFS)
大体时间：Up to Approximately 48 Months or 4 Years

PFS per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Disease control rate (DCR)
大体时间：Up to Approximately 48 Months or 4 Years

DCR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Overall survival (OS)
大体时间：Up to Approximately 48 Months or 4 Years

OS per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 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

Eli Lilly and Company

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2024年7月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2024年6月13日

首先提交符合 QC 标准的

2024年6月13日

首次发布 (实际的)

2024年6月18日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 18882
  • LOXO-LNC-24001 (其他标识符：Eli Lilly and Company)
  • J5I-OX-JZYA (其他标识符：Eli Lilly and Company)
  • 2024-512927-36-00 (克蒂斯)

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

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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