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Un estudio de Patritumab Deruxtecan en participantes pediátricos con tumores sólidos recurrentes o refractarios (MK-9999-01C/Lightbeam-U01)

2 de octubre de 2026 actualizado por: Merck Sharp & Dohme LLC

Lightbeam-U01 Sustudy 01C: un subestudio de fase 1/2 para evaluar la seguridad y la eficacia de Patritumab Deruxtecan en participantes pediátricos con tumores sólidos recurrentes o refractarios

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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Toll Free Number
  • Número de teléfono: 1-888-577-8839
  • Correo electrónico: Trialsites@msd.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

1 mes a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

Otros nombres:
  • U3-1402
  • HER3-DXd
  • MK-1022

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1 and Part 2: Overall Survival (OS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck Sharp & Dohme LLC

Colaboradores

Daiichi Sankyo

Investigadores

  • Director de estudio: Medical Director, Merck Sharp & Dohme LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de mayo de 2025

Finalización primaria (Estimado)

30 de diciembre de 2030

Finalización del estudio (Estimado)

30 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

27 de febrero de 2025

Primero enviado que cumplió con los criterios de control de calidad

15 de abril de 2025

Publicado por primera vez (Actual)

23 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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