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Um estudo de patritumab de deruxtecan em participantes pediátricos com tumores sólidos recidivados ou refratários (MK-9999-01C/Lightbeam-U01)

2 de outubro de 2026 atualizado por: Merck Sharp & Dohme LLC

LightBeam-U01 Substudy 01c: uma fase 1/2 substituto para avaliar a segurança e a eficácia do patritumab deRuxtecan em participantes pediátricos com tumores sólidos recidivados ou refratários

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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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)

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

1 mês a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Patritumab Deruxtecan

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

IV Infusion

Outros nomes:
  • U3-1402
  • HER3-DXd
  • MK-1022

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Part 1 and Part 2: Overall Survival (OS)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Merck Sharp & Dohme LLC

Colaboradores

Daiichi Sankyo

Investigadores

  • Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de maio de 2025

Conclusão Primária (Estimado)

30 de dezembro de 2030

Conclusão do estudo (Estimado)

30 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

27 de fevereiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de abril de 2025

Primeira postagem (Real)

23 de abril de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 9999-01C
  • LIGHTBEAM-U01 (Outro identificador: MSD)
  • MK-9999-01C (Outro identificador: MSD)
  • U1111-1314-1866 (Identificador de registro: UTN)
  • 2024-518771-66-00 (Identificador de registro: EU CT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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