Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Une étude de Patritumab Deruxecan chez les participants pédiatriques avec des tumeurs solides en rechute ou réfractaires (MK-9999-01C / Lightbeam-U01)

2 octobre 2026 mis à jour par: Merck Sharp & Dohme LLC

LightBeam-U01 Subdudy 01c: une substitution de phase 1/2 pour évaluer l'innocuité et l'efficacité de Patritumab Deruxecan chez les participants pédiatriques avec des tumeurs solides en rechute ou réfractaires

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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)

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 mois à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patritumab Deruxtecan

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

IV Infusion

Autres noms:
  • U3-1402
  • HER3-DXd
  • MK-1022

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Part 1 and Part 2: Overall Survival (OS)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck Sharp & Dohme LLC

Collaborateurs

Daiichi Sankyo

Les enquêteurs

  • Directeur d'études: Medical Director, Merck Sharp & Dohme LLC

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 mai 2025

Achèvement primaire (Estimé)

30 décembre 2030

Achèvement de l'étude (Estimé)

30 décembre 2030

Dates d'inscription aux études

Première soumission

27 février 2025

Première soumission répondant aux critères de contrôle qualité

15 avril 2025

Première publication (Réel)

23 avril 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 9999-01C
  • LIGHTBEAM-U01 (Autre identifiant: MSD)
  • MK-9999-01C (Autre identifiant: MSD)
  • U1111-1314-1866 (Identificateur de registre: UTN)
  • 2024-518771-66-00 (Identificateur de registre: EU CT)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner