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Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

NCT06395103 · Merck Sharp & Dohme LLC
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Official title
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
About this study
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 criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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. Exclusion Criteria: * History of solid organ transplant. * Clinically significant (ie, active) cardiovascular disease. * Known history of liver cirrhosis. * Ongoing Grade \>1 peripheral neuropathy. * Demyelinating form of Charcot-Marie-Tooth disease. * Diagnosed with Down syndrome. * Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis. * History of human immunodeficiency virus (HIV) infection. * Contraindication or hypersensitivity to any of the study intervention components. * Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities. * Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1). * Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Known additional malignancy that is progressing or has required active treatment within the past 1 year. * Active infection requiring systemic therapy. * Known history of Hepatitis B or known active Hepatitis C virus infection. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Study design
Enrollment target: 90 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2024-08-16
Estimated completion: 2029-03-31
Last updated: 2026-06-01
Interventions
Biological: Zilovertamab vedotin
Primary outcomes
  • Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT) (Up to 42 days)
  • Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs) (Up to approximately 54 months)
  • Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs (Up to approximately 54 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (69)
Children's Hospital Los Angeles ( Site 1006)Recruiting
Los Angeles, California, United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)Recruiting
Aurora, Colorado, United States
Yale New Haven Hospital ( Site 1012)Recruiting
New Haven, Connecticut, United States
Johns Hopkins All Children's Hospital ( Site 1025)Recruiting
St. Petersburg, Florida, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)Recruiting
Iowa City, Iowa, United States
Dana-Farber Cancer Institute ( Site 1013)Recruiting
Boston, Massachusetts, United States
Corewell Health ( Site 1001)Recruiting
Grand Rapids, Michigan, United States
Children's Mercy Hospital ( Site 1024)Recruiting
Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 1008)Recruiting
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center ( Site 1010)Recruiting
New York, New York, United States
New York Medical College ( Site 1023)Recruiting
Valhalla, New York, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)Recruiting
Fargo, North Dakota, United States
Oregon Health and Science University ( Site 1004)Recruiting
Portland, Oregon, United States
Children's Hospital of Philadelphia (CHOP) ( Site 1021)Recruiting
Philadelphia, Pennsylvania, United States
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)Recruiting
Sioux Falls, South Dakota, United States
University of Texas MD Anderson Cancer Center ( Site 1007)Recruiting
Houston, Texas, United States
Intermountain - Primary Children's Hospital ( Site 1014)Recruiting
Salt Lake City, Utah, United States
Sydney Children's Hospital ( Site 1997)Recruiting
Randwick, New South Wales, Australia
Queensland Children's Hospital-Oncology & Haematology ( Site 1996)Recruiting
Brisbane, Queensland, Australia
Royal Children's Hospital-Children's Cancer Centre ( Site 1994)Recruiting
Melbourne, Victoria, Australia
UZ Gent ( Site 1428)Recruiting
Ghent, Oost-Vlaanderen, Belgium
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)Completed
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre ( Site 1265)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)Recruiting
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)Recruiting
São José do Rio Preto, São Paulo, Brazil
The Hospital for Sick Children ( Site 1225)Recruiting
Toronto, Ontario, Canada
McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)Recruiting
Montreal, Quebec, Canada
Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)Recruiting
Concepción, Biobio, Chile
Hospital Luis Calvo Mackenna ( Site 1879)Recruiting
Santiago, Region M. de Santiago, Chile
Hospital Carlos Van Buren ( Site 1880)Recruiting
Valparaíso, Valparaiso, Chile
Hospital Pablo Tobon Uribe ( Site 1923)Recruiting
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)Recruiting
Barranquilla, Atlántico, Colombia
IMAT S.A.S ( Site 1921)Recruiting
Montería, Departamento de Córdoba, Colombia
Detska nemocnice FN Brno ( Site 1388)Recruiting
Brno, Brno-mesto, Czechia
Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)Recruiting
Prague, Praha 5, Czechia
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)Recruiting
Copenhagen, Capital Region, Denmark
CHU de Bordeaux. Hopital Pellegrin ( Site 1105)Recruiting
Bordeaux, Aquitaine, France
CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)Recruiting
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)Recruiting
Nantes, Loire-Atlantique, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)Recruiting
Marseille, Provence-Alpes-Côte d'Azur Region, France
Gustave Roussy ( Site 1103)Recruiting
Villejuif, Île-de-France Region, France
Universitaetsklinikum Tuebingen ( Site 1142)Recruiting
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)Recruiting
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)Recruiting
Münster, North Rhine-Westphalia, Germany
Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)Recruiting
Berlin, Germany
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)Recruiting
Athens, Attica, Greece
Semmelweis Egyetem ( Site 1838)Recruiting
Budapest, Hungary
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)Recruiting
Haifa, Israel
Sheba Medical Center ( Site 1675)Recruiting
Ramat Gan, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)Recruiting
Milan, Lombardy, Italy
Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)Recruiting
Rome, Roma, Italy
Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)Recruiting
Torino, Italy
Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)Recruiting
Utrecht, Netherlands
Narodny ustav detskych chorob ( Site 1592)Recruiting
Bratislava, Bratislava Region, Slovakia
Seoul National University Hospital-Pediatrics ( Site 1972)Recruiting
Seoul, South Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)Recruiting
Seoul, South Korea
Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)Recruiting
Esplugas de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)Recruiting
Barcelona, Spain
Sahlgrenska Universitetssjukhuset ( Site 1634)Recruiting
Gothenburg, Västra Götaland County, Sweden
National Taiwan University Hospital ( Site 1983)Recruiting
Taipei, Taiwan
Ege Universitesi Hastanesi ( Site 1963)Recruiting
Bornova, İzmir, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1961)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1962)Recruiting
Ankara, Turkey (Türkiye)
Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)Recruiting
Birmingham, England, United Kingdom
Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)Recruiting
Newcastle upon Tyne, England, United Kingdom
University College London Hospital ( Site 1350)Recruiting
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)Recruiting
Sutton, Surrey, United Kingdom
University Hospital of Wales ( Site 1346)Recruiting
Cardiff, United Kingdom
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) · TrialPath