Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een studie van Patritumab Deruxtecan bij pediatrische deelnemers met recidiverende of refractaire vaste tumoren (MK-9999-01C/LightBeam-U01)

2 oktober 2026 bijgewerkt door: Merck Sharp & Dohme LLC

LightBeam-U01 Substudy 01C: een fase 1/2 substudy om de veiligheid en werkzaamheid van Patritumab Deruxtecan bij pediatrische deelnemers met recidiverende of refractaire vaste tumoren te evalueren

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 maand tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Patritumab Deruxtecan

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

IV Infusion

Andere namen:
  • U3-1402
  • HER3-DXd
  • MK-1022

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1 and Part 2: Overall Survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Medewerkers

Daiichi Sankyo

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

26 mei 2025

Primaire voltooiing (Geschat)

30 december 2030

Studie voltooiing (Geschat)

30 december 2030

Studieregistratiedata

Eerst ingediend

27 februari 2025

Eerst ingediend dat voldeed aan de QC-criteria

15 april 2025

Eerst geplaatst (Werkelijk)

23 april 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

2 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 9999-01C
  • LIGHTBEAM-U01 (Andere identificatie: MSD)
  • MK-9999-01C (Andere identificatie: MSD)
  • U1111-1314-1866 (Register-ID: UTN)
  • 2024-518771-66-00 (Register-ID: EU CT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren