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Badanie deruxtecanu Patritumab u uczestników pediatrycznych z nawrotowymi lub opornymi guzami litymi (MK-9999-01C/Lighbeam-U01)

2 października 2026 zaktualizowane przez: Merck Sharp & Dohme LLC

Lighbeam-U01 Podstawa 01c: Podstanie fazy 1/2 oceny bezpieczeństwa i skuteczności deruxtecan Patritumab u uczestników pediatry

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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)

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

1 miesiąc do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Patritumab Deruxtecan

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

IV Infusion

Inne nazwy:
  • U3-1402
  • HER3-DXd
  • MK-1022

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Part 1 and Part 2: Overall Survival (OS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Merck Sharp & Dohme LLC

Współpracownicy

Daiichi Sankyo

Śledczy

  • Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 maja 2025

Zakończenie podstawowe (Szacowany)

30 grudnia 2030

Ukończenie studiów (Szacowany)

30 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

27 lutego 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 kwietnia 2025

Pierwszy wysłany (Rzeczywisty)

23 kwietnia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 9999-01C
  • LIGHTBEAM-U01 (Inny identyfikator: MSD)
  • MK-9999-01C (Inny identyfikator: MSD)
  • U1111-1314-1866 (Identyfikator rejestru: UTN)
  • 2024-518771-66-00 (Identyfikator rejestru: EU CT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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