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Studie Patritumab deruxtecan u dětských účastníků s relapsovanými nebo refrakterními pevnými nádory (MK-9999-01C/Lightbeam-U01)

2. října 2026 aktualizováno: Merck Sharp & Dohme LLC

Náhrada LightBeam-U01 01C: Fáze 1/2 Subsudy k vyhodnocení bezpečnosti a účinnosti Patritumab deruxtecan u dětských účastníků s relapsovanými nebo žáruvzdornými pevnými nádory

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

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

1 měsíc až 17 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Patritumab Deruxtecan

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

IV Infusion

Ostatní jména:
  • U3-1402
  • HER3-DXd
  • MK-1022

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1 and Part 2: Overall Survival (OS)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Spolupracovníci

Daiichi Sankyo

Vyšetřovatelé

  • Ředitel studie: Medical Director, Merck Sharp & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. května 2025

Primární dokončení (Odhadovaný)

30. prosince 2030

Dokončení studie (Odhadovaný)

30. prosince 2030

Termíny zápisu do studia

První předloženo

27. února 2025

První předloženo, které splnilo kritéria kontroly kvality

15. dubna 2025

První zveřejněno (Aktuální)

23. dubna 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 9999-01C
  • LIGHTBEAM-U01 (Jiný identifikátor: MSD)
  • MK-9999-01C (Jiný identifikátor: MSD)
  • U1111-1314-1866 (Identifikátor registru: UTN)
  • 2024-518771-66-00 (Identifikátor registru: EU CT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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