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Uno studio di Patritumab Deruxtecan in partecipanti pediatrici con tumori solidi recidivati ​​o refrattari (MK-9999-01C/Lightbeam-U01)

2 ottobre 2026 aggiornato da: Merck Sharp & Dohme LLC

Lightbeam-U01 Sostituzione 01C: un sottostudio di fase 1/2 per valutare la sicurezza e l'efficacia di patritumab deruxtecan nei partecipanti pediatrici con tumori solidi recidivati ​​o refrattari

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 mese a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Patritumab Deruxtecan

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

IV Infusion

Altri nomi:
  • U3-1402
  • HER3-DXd
  • MK-1022

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1 and Part 2: Overall Survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Collaboratori

Daiichi Sankyo

Investigatori

  • Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 maggio 2025

Completamento primario (Stimato)

30 dicembre 2030

Completamento dello studio (Stimato)

30 dicembre 2030

Date di iscrizione allo studio

Primo inviato

27 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

15 aprile 2025

Primo Inserito (Effettivo)

23 aprile 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 9999-01C
  • LIGHTBEAM-U01 (Altro identificatore: MSD)
  • MK-9999-01C (Altro identificatore: MSD)
  • U1111-1314-1866 (Identificatore di registro: UTN)
  • 2024-518771-66-00 (Identificatore di registro: EU CT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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