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对患有复发或难治性实体瘤的小儿参与者的patritumab deruxtecan的研究（MK-9999-01C/Lightbeam-U01）

2026年10月2日 更新者：Merck Sharp & Dohme LLC

Lightbeam-U01 bessudy 01c：一种1/2阶段的探针，用于评估patritumab deruxtecan在具有复发或难治性实体瘤的儿科参与者中的安全性和功效

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory:

  • Hepatoblastoma is a common liver cancer in babies and very young children
  • RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs
  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment

The study treatment HER3-DXd (also known as MK-1022 or patritumab 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 HER3-DXd in children and if they tolerate it
  • What happens to HER3-DXd in children's bodies over time
  • If children who receive HER3-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: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2)

研究类型

介入性

注册 (估计的)

50

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-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)
        • 接触：
          • Study Coordinator
          • 电话号码：+4535452462
  • 以色列
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus ( Site 3674)
        • 接触：
          • Study Coordinator
          • 电话号码：97247774718
      • Ramat Gan、以色列、5265601
        • 招聘中
        • Sheba Medical Center ( Site 3675)
        • 接触：
          • Study Coordinator
          • 电话号码：+97235302996
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T3B 6A8
        • 招聘中
        • Alberta Children's Hospital ( Site 3227)
        • 接触：
          • Study Coordinator
          • 电话号码：403-955-7203
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1X8
        • 招聘中
        • The Hospital for Sick Children ( Site 3225)
        • 接触：
          • Study Coordinator
          • 电话号码：4168131500
  • 匈牙利
    • Pest County
      • Budapest、Pest County、匈牙利、1094
        • 招聘中
        • Semmelweis University ( Site 3838)
        • 接触：
          • Study Coordinator
          • 电话号码：+3612151380
  • 台湾
    • Taipei
      • Taiwan、Taipei、台湾、10002
        • 招聘中
        • National Taiwan University Hospital ( Site 3983)
        • 接触：
          • Study Coordinator
          • 电话号码：8862-23123456#70559
  • 哥伦比亚
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、05034
        • 招聘中
        • Hospital Pablo Tobon Uribe ( Site 3923)
        • 接触：
          • Study Coordinator
          • 电话号码：+57 3006523572
    • Atlántico
      • Barranquilla、Atlántico、哥伦比亚、080020
        • 招聘中
        • Clinica de la Costa S.A.S. ( Site 3924)
        • 接触：
          • Study Coordinator
          • 电话号码：+573008096054
    • Departamento de Córdoba
      • Montería、Departamento de Córdoba、哥伦比亚、230002
        • 招聘中
        • IMAT S.A.S ( Site 3921)
        • 接触：
          • Study Coordinator
          • 电话号码：+576047862333
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06230
        • 招聘中
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)
        • 接触：
          • Study Coordinator
          • 电话号码：+90 312 305 50 00
      • Ankara、土耳其（türkiye）、6800
        • 招聘中
        • Ankara Bilkent Şehir Hastanesi. ( Site 3962)
        • 接触：
          • Study Coordinator
          • 电话号码：+90 312 552 60 00
      • Izmir、土耳其（türkiye）、35100
        • 招聘中
        • Ege Universitesi Hastanesi ( Site 3963)
        • 接触：
          • Study Coordinator
          • 电话号码：+905301469380
  • 巴西
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90035-903
        • 招聘中
        • Hospital de Clinicas de Porto Alegre ( Site 3265)
        • 接触：
          • Study Coordinator
          • 电话号码：+5551980139616
    • São Paulo
      • Barretos、São Paulo、巴西、14784-400
        • 招聘中
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)
        • 接触：
          • Study Coordinator
          • 电话号码：+551733216638
      • São José do Rio Preto、São Paulo、巴西、15090-000
        • 招聘中
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)
        • 接触：
          • Study Coordinator
          • 电话号码：+55 17 99625-3919
  • 希腊
    • Attica
      • Athens、Attica、希腊、11527
        • 招聘中
        • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)
        • 接触：
          • Study Coordinator
          • 电话号码：+302107452125
  • 德国
    • Baden-Wurttemberg
      • Tübingen、Baden-Wurttemberg、德国、72076
        • 招聘中
        • UniversitaetsklInikum Tuebingen ( Site 3142)
        • 接触：
          • Study Coordinator
          • 电话号码：+4970712981469
    • North Rhine-Westphalia
      • Cologne、North Rhine-Westphalia、德国、50937
        • 招聘中
        • Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 3145)
        • 接触：
          • Study Coordinator
          • 电话号码：0049221 478 6831
      • Münster、North Rhine-Westphalia、德国、48149
        • 招聘中
        • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)
        • 接触：
          • Study Coordinator
          • 电话号码：+492518347742
  • 意大利
      • Milan、意大利、20133
        • 招聘中
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)
        • 接触：
          • Study Coordinator
          • 电话号码：00390223902593
      • Roma、意大利、00165
        • 招聘中
        • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)
        • 接触：
          • Study Coordinator
          • 电话号码：00390668593697
      • Torino、意大利、10126
        • 招聘中
        • Ospedale Infantile Regina Margherita ( Site 3551)
        • 接触：
          • Study Coordinator
          • 电话号码：00390113135230
  • 捷克语
    • Brno-mesto
      • Brno、Brno-mesto、捷克语、613 00
        • 招聘中
        • Detska nemocnice FN Brno ( Site 3388)
        • 接触：
          • Study Coordinator
          • 电话号码：+420532234755
    • Praha 5
      • Prague、Praha 5、捷克语、150 00
        • 招聘中
        • Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)
        • 接触：
          • Study Coordinator
          • 电话号码：+420224436475
  • 斯洛伐克
    • Bratislava Region
      • Bratislava、Bratislava Region、斯洛伐克、833 40
        • 招聘中
        • Narodny ustav detskych chorob ( Site 3592)
        • 接触：
          • Study Coordinator
          • 电话号码：+421259371205
  • 智利
    • Valparaiso
      • Valparaíso、Valparaiso、智利、2341131
        • 招聘中
        • Hospital Carlos Van Buren ( Site 3880)
        • 接触：
          • Study Coordinator
          • 电话号码：56978546125
  • 比利时
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、比利时、9000
        • 招聘中
        • UZ Gent ( Site 3428)
        • 接触：
          • Study Coordinator
          • 电话号码：+3293324812
  • 法国
    • Aquitaine
      • Bordeaux、Aquitaine、法国、33076
        • 招聘中
        • Bordeaux University Hospital - Pellegrin ( Site 3105)
        • 接触：
          • Study Coordinator
          • 电话号码：+33556795679
    • Bouches-du-Rhone
      • Marseille、Bouches-du-Rhone、法国、13005
        • 招聘中
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)
        • 接触：
          • Study Coordinator
          • 电话号码：+33491385238
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、法国、44093
        • 招聘中
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)
        • 接触：
          • Study Coordinator
          • 电话号码：+33240083610
    • Rhone
      • Lyon、Rhone、法国、69373
        • 招聘中
        • Centre Leon-Berard ( Site 3100)
        • 接触：
          • Study Coordinator
          • 电话号码：33469166572
    • Île-de-France Region
      • Paris、Île-de-France Region、法国、75248
        • 招聘中
        • Institut Curie ( Site 3101)
        • 接触：
          • Study Coordinator
          • 电话号码：+33144324015
  • 澳大利亚
    • New South Wales
      • Sydney、New South Wales、澳大利亚、2031
        • 招聘中
        • Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)
        • 接触：
          • Study Coordinator
          • 电话号码：61293821111
    • Queensland
      • Brisbane、Queensland、澳大利亚、4101
        • 招聘中
        • Queensland Children's Hospital ( Site 3996)
        • 接触：
          • Study Coordinator
          • 电话号码：61730681111
    • Victoria
      • Parkville、Victoria、澳大利亚、3052
        • 招聘中
        • Royal Children's Hospital ( Site 3994)
        • 接触：
          • Study Coordinator
          • 电话号码：61393455522
  • 瑞典
    • Västra Götaland County
      • Gothenburg、Västra Götaland County、瑞典、416 85
        • 招聘中
        • Sahlgrenska Universitetssjukhuset ( Site 3634)
        • 接触：
          • Study Coordinator
          • 电话号码：+46313435865
  • 美国
    • California
      • Los Angeles、California、美国、90027
        • 招聘中
        • Childrens Hospital Los Angeles ( Site 3006)
        • 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 3016)
        • 接触：
          • Study Coordinator
          • 电话号码：720-777-1234
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 招聘中
        • Yale New Haven Hospital ( Site 3012)
        • 接触：
          • Study Coordinator
          • 电话号码：203-785-4640
    • Florida
      • St. Petersburg、Florida、美国、33701
        • 招聘中
        • Johns Hopkins All Children's Hospital ( Site 3025)
        • 接触：
          • Study Coordinator
          • 电话号码：727-767-4176
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
        • 接触：
          • Study Coordinator
          • 电话号码：319-356-2296
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Dana-Farber Cancer Institute ( Site 3013)
        • 接触：
          • Study Coordinator
          • 电话号码：617-632-4580
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Corewell Health ( Site 3001)
        • 接触：
          • Study Coordinator
          • 电话号码：616-486-0746
    • Missouri
      • Kansas City、Missouri、美国、64108
        • 招聘中
        • Children's Mercy Hospital ( Site 3024)
        • 接触：
          • Study Coordinator
          • 电话号码：816-302-6808
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • 招聘中
        • Rutgers Cancer Institute of New Jersey ( Site 3008)
        • 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 3010)
        • 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 3023)
        • 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 3003)
        • 接触：
          • Study Coordinator
          • 电话号码：701-234-2000
    • Oregon
      • Portland、Oregon、美国、97239
        • 招聘中
        • Oregon Health and Science University ( Site 3004)
        • 接触：
          • Study Coordinator
          • 电话号码：503-494-8311
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Children's Hospital of Philadelphia (CHOP) ( Site 3021)
        • 接触：
          • Study Coordinator
          • 电话号码：267-425-5544
    • South Dakota
      • Sioux Falls、South Dakota、美国、57117
        • 招聘中
        • Sanford Children's Hospital ( Site 3015)
        • 接触：
          • Study Coordinator
          • 电话号码：605-312-1000
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • University of Texas-MD Anderson Cancer Center ( Site 3007)
        • 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 3014)
        • 接触：
          • Study Coordinator
          • 电话号码：801-662-4700
  • 英国
      • Cardiff、英国、CF14 4XW
        • 招聘中
        • University Hospital of Wales ( Site 3346)
        • 接触：
          • Study Coordinator
          • 电话号码：+4402921842107
      • Sutton、英国、SM2 5PT
        • 招聘中
        • Royal Marsden Hospital ( Site 3347)
        • 接触：
          • Study Coordinator
          • 电话号码：020 8642 6011
    • England
      • Birmingham、England、英国、B4 6NH
        • 招聘中
        • Birmingham Children's Hospital ( Site 3349)
        • 接触：
          • Study Coordinator
          • 电话号码：+441213338233
      • Newcastle upon Tyne、England、英国、NE1 4PL
        • 招聘中
        • Royal Victoria Infirmary ( Site 3348)
        • 接触：
          • Study Coordinator
          • 电话号码：0191 282 1014
  • 荷兰
      • Utrecht、荷兰、3584 CS
        • 招聘中
        • Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
        • 接触：
          • Study Coordinator
          • 电话号码：+31889727272
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall d''Hebron ( Site 3716)
        • 接触：
          • Study Coordinator
          • 电话号码：+34915035900x662
      • Madrid、西班牙、28009
        • 招聘中
        • Hospital Infantil Universitario Nino Jesus ( Site 3715)
        • 接触：
          • Study Coordinator
          • 电话号码：+34915035900
    • Barcelona
      • Esplugues de Llobregat、Barcelona、西班牙、08950
        • 招聘中
        • Hospital Sant Joan de Déu ( Site 3717)
        • 接触：
          • Study Coordinator
          • 电话号码：+34671600093
  • 韩国
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital-Pediatrics ( Site 3972)
        • 接触：
          • Study Coordinator
          • 电话号码：+82220723304
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)
        • 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

1个月 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

  • Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma
  • Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens)
  • Participants who have adverse events (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. Participants with Grade ≤2 alopecia are also eligible
  • Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

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

  • Has a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD/pneumonitis, or suspected ILD/pneumonitis, or ILD that cannot be ruled out by imaging
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
  • Has a history of solid organ transplant
  • Has a history of allogeneic stem cell transplant
  • Has clinically significant corneal disease
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks
  • Has uncontrolled or significant cardiovascular disorder
  • Has a history of clinically significant congenital cardiac syndrome
  • Has a history of human immunodeficiency virus (HIV) infection
  • Has a known additional malignancy that is progressing or has required active treatment within the past 1 year
  • Has an active infection requiring systemic therapy
  • Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid [RNA]) infection
  • Has 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：Patritumab Deruxtecan

Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.
生物：Patritumab Deruxtecan

IV Infusion

其他名称：
  • U3-1402
  • HER3-DXd
  • MK-1022

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: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
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: Percentage of Participants Who Experience an Adverse Event (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: Percentage of Participants 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: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 1: AUC of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 1: Cmax of anti-HER3-ac-DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 1: Cmax of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
At designated timepoints (up to approximately 5 years)
Part 1: Ctrough of anti-HER3-ac-DXd
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
At designated timepoints (up to approximately 5 years)
Part 1: Ctrough of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Objective Response Rate (ORR)
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) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years

次要结果测量

结果测量
措施说明
大体时间
Part 1 and Part 2: Overall Survival (OS)
大体时间：Up to approximately 5 years

OS is defined as time from first dose of study treatment to death due to any cause.
Up to approximately 5 years
Part 2: Percentage of Participants 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 2: Percentage of Participants 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: Disease Control Rate (DCR)
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)
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: Duration of Response (DOR)
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: Progression-free Survival (PFS)
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 2: AUC of total anti-HER3 antibody LC-MS in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 2: AUC of anti-HER3-ac-DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 2: AUC of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of AUC.
At designated timepoints (up to approximately 5 years)
Part 2: Cmax of anti-HER3 antibody LC-MS in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 2: Cmax of anti-HER3-ac-DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 2: Cmax of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Cmax.
At designated timepoints (up to approximately 5 years)
Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
At designated timepoints (up to approximately 5 years)
Part 2: Ctrough of anti-HER3-ac-DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
At designated timepoints (up to approximately 5 years)
Part 2: Ctrough of DXd in plasma
大体时间：At designated timepoints (up to approximately 5 years)

Blood samples will be collected at specified intervals for the determination of Ctrough.
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)

2025年5月26日

初级完成 (估计的)

2030年12月30日

研究完成 (估计的)

2030年12月30日

研究注册日期

首次提交

2025年2月27日

首先提交符合 QC 标准的

2025年4月15日

首次发布 (实际的)

2025年4月23日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月2日

最后验证

2026年10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

  • 9999-01C
  • LIGHTBEAM-U01 (其他标识符：MSD)
  • MK-9999-01C (其他标识符：MSD)
  • U1111-1314-1866 (注册表标识符：UTN)
  • 2024-518771-66-00 (注册表标识符：EU CT)

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.

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