이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

재발 또는 내화성 고형 종양을 가진 소아 참가자의 Patritumab deruxtecan에 대한 연구 (MK-9999-01C/Lightbeam-U01)

2026년 10월 2일 업데이트: Merck Sharp & Dohme LLC

Lightbeam-U01 Substudy 01C : 재발 성 또는 내화성 고형 종양을 가진 소아 참가자에서 Patritumab Deruxtecan의 안전성 및 효능을 평가하기위한 1/2 단계 참조.

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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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)

연구 유형

중재적

등록 (추정된)

50

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1개월 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Patritumab Deruxtecan

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

IV Infusion

다른 이름들:
  • U3-1402
  • HER3-DXd
  • MK-1022

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Part 1 and Part 2: Overall Survival (OS)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

협력자

Daiichi Sankyo

수사관

  • 연구 책임자: Medical Director, Merck Sharp & Dohme LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 26일

기본 완료 (추정된)

2030년 12월 30일

연구 완료 (추정된)

2030년 12월 30일

연구 등록 날짜

최초 제출

2025년 2월 27일

QC 기준을 충족하는 최초 제출

2025년 4월 15일

처음 게시됨 (실제)

2025년 4월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 9999-01C
  • LIGHTBEAM-U01 (기타 식별자: MSD)
  • MK-9999-01C (기타 식별자: MSD)
  • U1111-1314-1866 (레지스트리 식별자: UTN)
  • 2024-518771-66-00 (레지스트리 식별자: EU CT)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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