A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Start Date
5/26/2025
Completion Date
12/30/2030
Summary
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
Detailed Description
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)
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Patritumab Deruxtecan
Conditions
Locations
Childrens Hospital Los Angeles ( Site 3006)
Los Angeles, California 90027
United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
Aurora, Colorado 80045
United States
Yale New Haven Hospital ( Site 3012)
New Haven, Connecticut 06510
United States
Johns Hopkins All Children's Hospital ( Site 3025)
St. Petersburg, Florida 33701
United States
University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
Iowa City, Iowa 52242
United States
Dana-Farber Cancer Institute ( Site 3013)
Boston, Massachusetts 02215
United States
Corewell Health ( Site 3001)
Grand Rapids, Michigan 49503
United States
Children's Mercy Hospital ( Site 3024)
Kansas City, Missouri 64108
United States
Rutgers Cancer Institute of New Jersey ( Site 3008)
New Brunswick, New Jersey 08901
United States
Memorial Sloan Kettering Cancer Center ( Site 3010)
New York, New York 10065
United States
New York Medical College ( Site 3023)
Valhalla, New York 10595
United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)
Fargo, North Dakota 58102
United States
Oregon Health and Science University ( Site 3004)
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia (CHOP) ( Site 3021)
Philadelphia, Pennsylvania 19104
United States
Sanford Children's Hospital ( Site 3015)
Sioux Falls, South Dakota 57117
United States
University of Texas-MD Anderson Cancer Center ( Site 3007)
Houston, Texas 77030
United States
Intermountain - Primary Children's Hospital ( Site 3014)
Salt Lake City, Utah 84113
United States
Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)
Sydney, New South Wales 2031
Australia
Queensland Children's Hospital ( Site 3996)
Brisbane, Queensland 4101
Australia
Royal Children's Hospital ( Site 3994)
Parkville, Victoria 3052
Australia
UZ Gent ( Site 3428)
Ghent, Oost-Vlaanderen 9000
Belgium
Hospital de Clinicas de Porto Alegre ( Site 3265)
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)
Barretos, São Paulo 14784-400
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)
São José do Rio Preto, São Paulo 15090-000
Brazil
Alberta Children's Hospital ( Site 3227)
Calgary, Alberta T3B 6A8
Canada
The Hospital for Sick Children ( Site 3225)
Toronto, Ontario M5G 1X8
Canada
Hospital Carlos Van Buren ( Site 3880)
Valparaíso, Valparaiso 2341131
Chile
Hospital Pablo Tobon Uribe ( Site 3923)
Medellín, Antioquia 05034
Colombia
Clinica de la Costa S.A.S. ( Site 3924)
Barranquilla, Atlántico 080020
Colombia
IMAT S.A.S ( Site 3921)
Montería, Departamento de Córdoba 230002
Colombia
Detska nemocnice FN Brno ( Site 3388)
Brno, Brno-mesto 613 00
Czechia
Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)
Prague, Praha 5 150 00
Czechia
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)
Copenhagen, Capital Region DK-2100
Denmark
Bordeaux University Hospital - Pellegrin ( Site 3105)
Bordeaux, Aquitaine 33076
France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)
Marseille, Bouches-du-Rhone 13005
France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)
Nantes, Loire-Atlantique 44093
France
Centre Leon-Berard ( Site 3100)
Lyon, Rhone 69373
France
Institut Curie ( Site 3101)
Paris, Île-de-France Region 75248
France
UniversitaetsklInikum Tuebingen ( Site 3142)
Tübingen, Baden-Wurttemberg 72076
Germany
Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)
Münster, North Rhine-Westphalia 48149
Germany
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)
Athens, Attica 11527
Greece
Semmelweis University ( Site 3838)
Budapest, Pest County 1094
Hungary
Rambam Health Care Campus ( Site 3674)
Haifa, 3109601
Israel
Sheba Medical Center ( Site 3675)
Ramat Gan, 5265601
Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)
Milan, 20133
Italy
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)
Roma, 00165
Italy
Ospedale Infantile Regina Margherita ( Site 3551)
Torino, 10126
Italy
Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
Utrecht, 3584 CS
Netherlands
Narodny ustav detskych chorob ( Site 3592)
Bratislava, Bratislava Region 831 01
Slovakia
Seoul National University Hospital-Pediatrics ( Site 3972)
Seoul, 03080
South Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)
Seoul, 05505
South Korea
Hospital Sant Joan de Déu ( Site 3717)
Esplugues de Llobregat, Barcelona 08950
Spain
Hospital Universitari Vall d''Hebron ( Site 3716)
Barcelona, 08035
Spain
Hospital Infantil Universitario Nino Jesus ( Site 3715)
Madrid, 28009
Spain
Sahlgrenska Universitetssjukhuset ( Site 3634)
Gothenburg, Västra Götaland County 416 85
Sweden
National Taiwan University Hospital ( Site 3983)
Taiwan, Taipei 10002
Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 3962)
Ankara, 6800
Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 3963)
Izmir, 35100
Turkey (Türkiye)
Birmingham Children's Hospital ( Site 3349)
Birmingham, England B4 6NH
United Kingdom
Royal Victoria Infirmary ( Site 3348)
Newcastle upon Tyne, England NE1 4PL
United Kingdom
University Hospital of Wales ( Site 3346)
Cardiff, CF14 4XW
United Kingdom
Royal Marsden Hospital ( Site 3347)
Sutton, SM2 5PT
United Kingdom