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再発または難治性固形腫瘍を持つ小児の参加者におけるパトリツマブderuxtecanの研究（MK-9999-01C/LightBeam-U01）

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

Lightbeam-U01 Sududy 01c：再発または難治性固形腫瘍を持つ小児の参加者におけるパトリツマブDeruxtecanの安全性と有効性を評価するための第1/2 study相

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

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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)

研究の種類

介入

入学 (推定)

50

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90027
        • 募集
        • Childrens Hospital Los Angeles ( Site 3006)
        • コンタクト：
          • Study Coordinator
          • 電話番号：323-361-2121
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • 募集
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
        • コンタクト：
          • Study Coordinator
          • 電話番号：720-777-1234
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • 募集
        • Yale New Haven Hospital ( Site 3012)
        • コンタクト：
          • Study Coordinator
          • 電話番号：203-785-4640
    • Florida
      • St. Petersburg、Florida、アメリカ、33701
        • 募集
        • Johns Hopkins All Children's Hospital ( Site 3025)
        • コンタクト：
          • Study Coordinator
          • 電話番号：727-767-4176
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • 募集
        • University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
        • コンタクト：
          • Study Coordinator
          • 電話番号：319-356-2296
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana-Farber Cancer Institute ( Site 3013)
        • コンタクト：
          • Study Coordinator
          • 電話番号：617-632-4580
    • Michigan
      • Grand Rapids、Michigan、アメリカ、49503
        • 募集
        • Corewell Health ( Site 3001)
        • コンタクト：
          • Study Coordinator
          • 電話番号：616-486-0746
    • Missouri
      • Kansas City、Missouri、アメリカ、64108
        • 募集
        • Children's Mercy Hospital ( Site 3024)
        • コンタクト：
          • Study Coordinator
          • 電話番号：816-302-6808
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • 募集
        • Rutgers Cancer Institute of New Jersey ( Site 3008)
        • コンタクト：
          • Study Coordinator
          • 電話番号：732-235-2465
    • New York
      • New York、New York、アメリカ、10065
        • 募集
        • Memorial Sloan Kettering Cancer Center ( Site 3010)
        • コンタクト：
          • Study Coordinator
          • 電話番号：888-492-8401
      • Valhalla、New York、アメリカ、10595
        • 募集
        • New York Medical College ( Site 3023)
        • コンタクト：
          • Study Coordinator
          • 電話番号：914-614-4270
    • North Dakota
      • Fargo、North Dakota、アメリカ、58102
        • 募集
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)
        • コンタクト：
          • Study Coordinator
          • 電話番号：701-234-2000
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • 募集
        • Oregon Health and Science University ( Site 3004)
        • コンタクト：
          • Study Coordinator
          • 電話番号：503-494-8311
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • 募集
        • Children's Hospital of Philadelphia (CHOP) ( Site 3021)
        • コンタクト：
          • Study Coordinator
          • 電話番号：267-425-5544
    • South Dakota
      • Sioux Falls、South Dakota、アメリカ、57117
        • 募集
        • Sanford Children's Hospital ( Site 3015)
        • コンタクト：
          • Study Coordinator
          • 電話番号：605-312-1000
    • Texas
      • Houston、Texas、アメリカ、77030
        • 募集
        • University of Texas-MD Anderson Cancer Center ( Site 3007)
        • コンタクト：
          • Study Coordinator
          • 電話番号：713-792-5410
    • Utah
      • Salt Lake City、Utah、アメリカ、84113
        • 募集
        • Intermountain - Primary Children's Hospital ( Site 3014)
        • コンタクト：
          • Study Coordinator
          • 電話番号：801-662-4700
  • イギリス
      • Cardiff、イギリス、CF14 4XW
        • 募集
        • University Hospital of Wales ( Site 3346)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+4402921842107
      • Sutton、イギリス、SM2 5PT
        • 募集
        • Royal Marsden Hospital ( Site 3347)
        • コンタクト：
          • Study Coordinator
          • 電話番号：020 8642 6011
    • England
      • Birmingham、England、イギリス、B4 6NH
        • 募集
        • Birmingham Children's Hospital ( Site 3349)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+441213338233
      • Newcastle upon Tyne、England、イギリス、NE1 4PL
        • 募集
        • Royal Victoria Infirmary ( Site 3348)
        • コンタクト：
          • Study Coordinator
          • 電話番号：0191 282 1014
  • イスラエル
      • Haifa、イスラエル、3109601
        • 募集
        • Rambam Health Care Campus ( Site 3674)
        • コンタクト：
          • Study Coordinator
          • 電話番号：97247774718
      • Ramat Gan、イスラエル、5265601
        • 募集
        • Sheba Medical Center ( Site 3675)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+97235302996
  • イタリア
      • Milan、イタリア、20133
        • 募集
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)
        • コンタクト：
          • Study Coordinator
          • 電話番号：00390223902593
      • Roma、イタリア、00165
        • 募集
        • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)
        • コンタクト：
          • Study Coordinator
          • 電話番号：00390668593697
      • Torino、イタリア、10126
        • 募集
        • Ospedale Infantile Regina Margherita ( Site 3551)
        • コンタクト：
          • Study Coordinator
          • 電話番号：00390113135230
  • オランダ
      • Utrecht、オランダ、3584 CS
        • 募集
        • Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+31889727272
  • オーストラリア
    • New South Wales
      • Sydney、New South Wales、オーストラリア、2031
        • 募集
        • Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)
        • コンタクト：
          • Study Coordinator
          • 電話番号：61293821111
    • Queensland
      • Brisbane、Queensland、オーストラリア、4101
        • 募集
        • Queensland Children's Hospital ( Site 3996)
        • コンタクト：
          • Study Coordinator
          • 電話番号：61730681111
    • Victoria
      • Parkville、Victoria、オーストラリア、3052
        • 募集
        • Royal Children's Hospital ( Site 3994)
        • コンタクト：
          • Study Coordinator
          • 電話番号：61393455522
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T3B 6A8
        • 募集
        • Alberta Children's Hospital ( Site 3227)
        • コンタクト：
          • Study Coordinator
          • 電話番号：403-955-7203
    • Ontario
      • Toronto、Ontario、カナダ、M5G 1X8
        • 募集
        • The Hospital for Sick Children ( Site 3225)
        • コンタクト：
          • Study Coordinator
          • 電話番号：4168131500
  • ギリシャ
    • Attica
      • Athens、Attica、ギリシャ、11527
        • 募集
        • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+302107452125
  • コロンビア
    • Antioquia
      • Medellín、Antioquia、コロンビア、05034
        • 募集
        • Hospital Pablo Tobon Uribe ( Site 3923)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+57 3006523572
    • Atlántico
      • Barranquilla、Atlántico、コロンビア、080020
        • 募集
        • Clinica de la Costa S.A.S. ( Site 3924)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+573008096054
    • Departamento de Córdoba
      • Montería、Departamento de Córdoba、コロンビア、230002
        • 募集
        • IMAT S.A.S ( Site 3921)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+576047862333
  • スウェーデン
    • Västra Götaland County
      • Gothenburg、Västra Götaland County、スウェーデン、416 85
        • 募集
        • Sahlgrenska Universitetssjukhuset ( Site 3634)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+46313435865
  • スペイン
      • Barcelona、スペイン、08035
        • 募集
        • Hospital Universitari Vall d''Hebron ( Site 3716)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34915035900x662
      • Madrid、スペイン、28009
        • 募集
        • Hospital Infantil Universitario Nino Jesus ( Site 3715)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34915035900
    • Barcelona
      • Esplugues de Llobregat、Barcelona、スペイン、08950
        • 募集
        • Hospital Sant Joan de Déu ( Site 3717)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34671600093
  • スロバキア
    • Bratislava Region
      • Bratislava、Bratislava Region、スロバキア、833 40
        • 募集
        • Narodny ustav detskych chorob ( Site 3592)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+421259371205
  • チェコ
    • Brno-mesto
      • Brno、Brno-mesto、チェコ、613 00
        • 募集
        • Detska nemocnice FN Brno ( Site 3388)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+420532234755
    • Praha 5
      • Prague、Praha 5、チェコ、150 00
        • 募集
        • Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+420224436475
  • チリ
    • Valparaiso
      • Valparaíso、Valparaiso、チリ、2341131
        • 募集
        • Hospital Carlos Van Buren ( Site 3880)
        • コンタクト：
          • Study Coordinator
          • 電話番号：56978546125
  • デンマーク
    • Capital Region
      • Copenhagen、Capital Region、デンマーク、DK-2100
        • 募集
        • Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+4535452462
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06230
        • 募集
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+90 312 305 50 00
      • Ankara、トルコ（Türkiye）、6800
        • 募集
        • Ankara Bilkent Şehir Hastanesi. ( Site 3962)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+90 312 552 60 00
      • Izmir、トルコ（Türkiye）、35100
        • 募集
        • Ege Universitesi Hastanesi ( Site 3963)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+905301469380
  • ドイツ
    • Baden-Wurttemberg
      • Tübingen、Baden-Wurttemberg、ドイツ、72076
        • 募集
        • UniversitaetsklInikum Tuebingen ( Site 3142)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+4970712981469
    • North Rhine-Westphalia
      • Cologne、North Rhine-Westphalia、ドイツ、50937
        • 募集
        • Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 3145)
        • コンタクト：
          • Study Coordinator
          • 電話番号：0049221 478 6831
      • Münster、North Rhine-Westphalia、ドイツ、48149
        • 募集
        • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+492518347742
  • ハンガリー
    • Pest County
      • Budapest、Pest County、ハンガリー、1094
        • 募集
        • Semmelweis University ( Site 3838)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+3612151380
  • フランス
    • Aquitaine
      • Bordeaux、Aquitaine、フランス、33076
        • 募集
        • Bordeaux University Hospital - Pellegrin ( Site 3105)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33556795679
    • Bouches-du-Rhone
      • Marseille、Bouches-du-Rhone、フランス、13005
        • 募集
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33491385238
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、フランス、44093
        • 募集
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33240083610
    • Rhone
      • Lyon、Rhone、フランス、69373
        • 募集
        • Centre Leon-Berard ( Site 3100)
        • コンタクト：
          • Study Coordinator
          • 電話番号：33469166572
    • Île-de-France Region
      • Paris、Île-de-France Region、フランス、75248
        • 募集
        • Institut Curie ( Site 3101)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33144324015
  • ブラジル
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
        • 募集
        • Hospital de Clinicas de Porto Alegre ( Site 3265)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+5551980139616
    • São Paulo
      • Barretos、São Paulo、ブラジル、14784-400
        • 募集
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+551733216638
      • São José do Rio Preto、São Paulo、ブラジル、15090-000
        • 募集
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+55 17 99625-3919
  • ベルギー
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、ベルギー、9000
        • 募集
        • UZ Gent ( Site 3428)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+3293324812
  • 台湾
    • Taipei
      • Taiwan、Taipei、台湾、10002
        • 募集
        • National Taiwan University Hospital ( Site 3983)
        • コンタクト：
          • Study Coordinator
          • 電話番号：8862-23123456#70559
  • 韓国
      • Seoul、韓国、03080
        • 募集
        • Seoul National University Hospital-Pediatrics ( Site 3972)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+82220723304
      • Seoul、韓国、05505
        • 募集
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+82230105994

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1ヶ月～17年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Patritumab Deruxtecan

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

IV Infusion

他の名前：
  • U3-1402
  • HER3-DXd
  • MK-1022

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1 and Part 2: Overall Survival (OS)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Merck Sharp & Dohme LLC

協力者

Daiichi Sankyo

捜査官

  • スタディディレクター：Medical Director、Merck Sharp & Dohme LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月26日

一次修了 (推定)

2030年12月30日

研究の完了 (推定)

2030年12月30日

試験登録日

最初に提出

2025年2月27日

QC基準を満たした最初の提出物

2025年4月15日

最初の投稿 (実際)

2025年4月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月2日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 9999-01C
  • LIGHTBEAM-U01 (その他の識別子：MSD)
  • MK-9999-01C (その他の識別子：MSD)
  • U1111-1314-1866 (レジストリ識別子：UTN)
  • 2024-518771-66-00 (レジストリ識別子：EU CT)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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