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 (29) 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
Connecticut
Yale-New Haven Hospital ( Site 1012)
RECRUITING
New Haven
Florida
Johns Hopkins All Children's Hospital ( Site 1025)
RECRUITING
Saint Petersburg
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
RECRUITING
Iowa City
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
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
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
RECRUITING
Barretos
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
RECRUITING
Curitiba
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
RECRUITING
São José Do Rio Preto
Denmark
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 14
RECRUITING
Copenhagen
France
CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)
RECRUITING
Lyon
Gustave Roussy ( Site 1103)
RECRUITING
Villejuif
Israel
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
RECRUITING
Haifa
Sheba Medical Center ( Site 1675)
RECRUITING
Ramat Gan
Republic of Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
RECRUITING
Seoul
Seoul National University Hospital-Pediatrics ( Site 1972)
RECRUITING
Seoul
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
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
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