LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors
Status: Recruiting
Location: See all (59) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 25
Healthy Volunteers: f
View:
• For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.
• For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.
Locations
United States
California
Children's Hospital Los Angeles ( Site 1006)
RECRUITING
Los Angeles
Colorado
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
RECRUITING
Aurora
Connecticut
Yale-New Haven Hospital ( Site 1012)
RECRUITING
New Haven
Florida
Johns Hopkins All Children's Hospital ( Site 1025)
RECRUITING
St. Petersburg
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
RECRUITING
Iowa City
Massachusetts
Dana-Farber Cancer Institute ( Site 1013)
RECRUITING
Boston
Michigan
Corewell Health ( Site 1001)
RECRUITING
Grand Rapids
Missouri
Children's Mercy Hospital ( Site 1024)
RECRUITING
Kansas City
North Dakota
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
RECRUITING
Fargo
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 1008)
RECRUITING
New Brunswick
New York
New York Medical College ( Site 1023)
RECRUITING
Valhalla
Oregon
Oregon Health and Science University ( Site 1004)
RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia (CHOP) ( Site 1021)
RECRUITING
Philadelphia
South Dakota
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
RECRUITING
Sioux Falls
Texas
University of Texas MD Anderson Cancer Center ( Site 1007)
RECRUITING
Houston
Utah
Intermountain - Primary Children's Hospital ( Site 1014)
RECRUITING
Salt Lake City
Other Locations
Australia
Queensland Children's Hospital-Oncology & Haematology ( Site 1996)
RECRUITING
Brisbane
Sydney Children's Hospital-Kids Cancer Centre ( Site 1997)
RECRUITING
Randwick
Belgium
UZ Gent ( Site 1428)
RECRUITING
Ghent
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
RECRUITING
Barretos
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
RECRUITING
Curitiba
Hospital de Clinicas de Porto Alegre ( Site 1265)
RECRUITING
Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)
RECRUITING
São José Do Rio Preto
Canada
McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)
RECRUITING
Montreal
Chile
Hospital Carlos Van Buren ( Site 1880)
RECRUITING
Valparaíso
Colombia
Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)
RECRUITING
Barranquilla
Hospital Pablo Tobon Uribe ( Site 1923)
RECRUITING
Medellín
IMAT S.A.S ( Site 1921)
RECRUITING
Montería
Denmark
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)
RECRUITING
Copenhagen
France
CHU de Bordeaux. Hopital Pellegrin ( Site 1105)
RECRUITING
Bordeaux
CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)
RECRUITING
Lyon
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)
RECRUITING
Nantes
Gustave Roussy ( Site 1103)
RECRUITING
Villejuif
Germany
Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)
RECRUITING
Berlin
Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)
RECRUITING
Münster
Greece
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)
RECRUITING
Athens
Hungary
Semmelweis Egyetem ( Site 1838)
RECRUITING
Budapest
Israel
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
RECRUITING
Haifa
Sheba Medical Center ( Site 1675)
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)
RECRUITING
Milan
Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)
RECRUITING
Rome
Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)
RECRUITING
Torino
Netherlands
Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)
RECRUITING
Utrecht
Republic of Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
RECRUITING
Seoul
Seoul National University Hospital-Pediatrics ( Site 1972)
RECRUITING
Seoul
Slovakia
Narodny ustav detskych chorob ( Site 1592)
RECRUITING
Bratislava
Spain
Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)
RECRUITING
Barcelona
Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)
RECRUITING
Esplugas De Llobregat
Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)
RECRUITING
Madrid
Sweden
Prövningsenhet barn, Sahlgrenska Universitetssjukhuset ( Site 1634)
RECRUITING
Gothenburg
Taiwan
National Taiwan University Hospital ( Site 1983)
RECRUITING
Taipei
Turkey
Ankara Bilkent Şehir Hastanesi ( Site 1962)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 1961)
RECRUITING
Ankara
Ege Universitesi Hastanesi ( Site 1963)
RECRUITING
Izmir
United Kingdom
University Hospital of Wales ( Site 1346)
RECRUITING
Cardiff
University College London Hospital ( Site 1350)
RECRUITING
London
Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
RECRUITING
Newcastle Upon Tyne
Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
RECRUITING
Sutton
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-08-16
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 90
Treatments
Experimental: Zilovertamab vedotin
Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC