此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

2026年9月15日 更新者：Merck Sharp & Dohme LLC

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study will have 2 parts: Part 1 will evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd, followed by Part 2 an efficacy expansion.

研究类型

介入性

注册 (估计的)

134

阶段

  • 阶段2
  • 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

  • 丹麦
    • Capital Region
      • Copenhagen、Capital Region、丹麦、DK-2100
        • 招聘中
        • Rigshospitalet ( Site 4467)
        • 接触：
          • Study Coordinator
          • 电话号码：+4535455002
  • 以色列
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus ( Site 4674)
        • 接触：
          • Study Coordinator
          • 电话号码：+97247776755
      • Ramat Gan、以色列、5265601
        • 招聘中
        • Sheba Medical Center ( Site 4675)
        • 接触：
          • Study Coordinator
          • 电话号码：+97235302996
  • 比利时
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、比利时、9000
        • 招聘中
        • UZ Gent ( Site 4428)
        • 接触：
          • Study Coordinator
          • 电话号码：+32 9 332 16 53
  • 法国
    • Aquitaine
      • Bordeaux、Aquitaine、法国、33076
        • 招聘中
        • Bordeaux University Hospital - Pellegrin ( Site 4105)
        • 接触：
          • Study Coordinator
          • 电话号码：+33 5 56 79 56 79
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、法国、44093
        • 招聘中
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
        • 接触：
          • Study Coordinator
          • 电话号码：+33240087805
    • Rhone
      • Lyon、Rhone、法国、69373
        • 招聘中
        • CENTRE LEON BERARD ( Site 4100)
        • 接触：
          • Study Coordinator
          • 电话号码：+33469166572
  • 瑞典
    • Västra Götaland County
      • Gothenburg、Västra Götaland County、瑞典、416 85
        • 招聘中
        • Sahlgrenska Universitetssjukhuset ( Site 4634)
        • 接触：
          • Study Coordinator
          • 电话号码：+46313435865
  • 美国
    • California
      • Los Angeles、California、美国、90027
        • 招聘中
        • Children's Hospital Los Angeles ( Site 4006)
        • 接触：
          • Study Coordinator
          • 电话号码：323-361-2121
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
        • 接触：
          • Study Coordinator
          • 电话号码：720-777-6740
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa Hospitals ( Site 4017)
        • 接触：
          • Study Coordinator
          • 电话号码：319-356-2296
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Dana Farber Cancer Center ( Site 4013)
        • 接触：
          • Study Coordinator
          • 电话号码：617-632-4580
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Corewell Health ( Site 4001)
        • 接触：
          • Study Coordinator
          • 电话号码：616-486-0746
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • 招聘中
        • Rutgers Cancer Institute of New Jersey ( Site 4008)
        • 接触：
          • Study Coordinator
          • 电话号码：732-235-2465
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center ( Site 4010)
        • 接触：
          • Study Coordinator
          • 电话号码：888-492-8401
      • Valhalla、New York、美国、10595
        • 招聘中
        • New York Medical College ( Site 4023)
        • 接触：
          • Study Coordinator
          • 电话号码：914-614-4270
    • North Dakota
      • Fargo、North Dakota、美国、58102
        • 招聘中
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
        • 接触：
          • Study Coordinator
          • 电话号码：701-234-2000
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Children's Hospital of Philadelphia (CHOP) ( Site 4021)
        • 接触：
          • Study Coordinator
          • 电话号码：267-425-5544
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • 招聘中
        • Sanford Children's Hospital ( Site 4015)
        • 接触：
          • Study Coordinator
          • 电话号码：605-312-1000
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • University of Texas M.D. Anderson Cancer Center ( Site 4007)
        • 接触：
          • Study Coordinator
          • 电话号码：713-792-5410
    • Utah
      • Salt Lake City、Utah、美国、84113
        • 招聘中
        • Intermountain - Primary Children's Hospital ( Site 4014)
        • 接触：
          • Study Coordinator
          • 电话号码：801-662-4700
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall d Hebron ( Site 4716)
        • 接触：
          • Study Coordinator
          • 电话号码：+34934893093
    • Barcelona
      • Esplugues de Llobregat、Barcelona、西班牙、8950
        • 招聘中
        • Hospital Sant Joan de Déu ( Site 4717)
        • 接触：
          • Study Coordinator
          • 电话号码：+34671600093
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28009
        • 招聘中
        • Hospital Niño Jesús ( Site 4715)
        • 接触：
          • Study Coordinator
          • 电话号码：+34915035900
  • 韩国
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital-Pediatrics ( Site 4972)
        • 接触：
          • Study Coordinator
          • 电话号码：82220723304
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
        • 接触：
          • Study Coordinator
          • 电话号码：82230105994

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

  • 孩子

接受健康志愿者

不

描述

The main inclusion criteria include but are not limited to the following:

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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：Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
生物：Ifinatamab Deruxtecan
IV infusion
其他名称：
  • DS-7300a
  • I-DXd
  • MK-2400

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
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
大体时间：Cycle 1 (up to approximately 21 days); each cycle is 21 days
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
大体时间：Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
大体时间：Up to 4 Months
DCS-4 is defined as no occurrence of disease progression per disease specific criteria as assessed by investigator or death due to any cause by Month 4 following the first administration of study intervention for participants with OST. Participants who discontinue from study for any reason prior to completing the third post baseline (or at least 16 weeks) response assessments will be considered disease control failures.
Up to 4 Months

次要结果测量

结果测量
措施说明
大体时间
第1部分和第2部分：整体生存（OS）
大体时间：大约5年
OS定义为从研究治疗到死亡的时间。
大约5年
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
大体时间：Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
大体时间：Up to approximately 5 years
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
大体时间：Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
大体时间：Up to approximately 5 years
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: ORR For participants with OST
大体时间：Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants with OST who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
大体时间：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of I-Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
大体时间：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to assess I-Dxd immunogenicity by determining the incidence of ADA of I-Dxd.
At designated timepoints (up to approximately 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

Merck Sharp & Dohme LLC

合作者

Daiichi Sankyo

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

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)

2026年7月6日

初级完成 (估计的)

2031年8月17日

研究完成 (估计的)

2031年8月17日

研究注册日期

首次提交

2026年6月1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9月17日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 9999-01D
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (其他标识符：MSD)
  • U1111-1322-6561 (注册表标识符：UTN)
  • 2025-522339-32-00 (注册表标识符：EU CT)
  • MK-9999-01D (其他标识符：MSD)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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.

订阅