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RECRUITING

NCT06395103

PHASE1/PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Months - 25 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-16

Completion Date

2029-03-31

Last Updated

2026-04-02

Healthy Volunteers

Conditions

B-cell Acute Lymphoblastic Leukemia Diffuse Large B-cell Lymphoma Burkitt Lymphoma Neuroblastoma Ewing Sarcoma

Interventions

BIOLOGICAL

Zilovertamab vedotin

Administered via IV infusion

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.

Locations (67)

Children's Hospital Los Angeles ( Site 1006)

Los Angeles, California, United States

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)

Aurora, Colorado, United States

Yale New Haven Hospital ( Site 1012)

New Haven, Connecticut, United States

Johns Hopkins All Children's Hospital ( Site 1025)

St. Petersburg, Florida, United States

University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)

Iowa City, Iowa, United States

Dana-Farber Cancer Institute ( Site 1013)

Boston, Massachusetts, United States

Corewell Health ( Site 1001)

Grand Rapids, Michigan, United States

Children's Mercy Hospital ( Site 1024)

Kansas City, Missouri, United States

Rutgers Cancer Institute of New Jersey ( Site 1008)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center ( Site 1010)

New York, New York, United States

New York Medical College ( Site 1023)

Valhalla, New York, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)

Fargo, North Dakota, United States

Oregon Health and Science University ( Site 1004)

Portland, Oregon, United States

Children's Hospital of Philadelphia (CHOP) ( Site 1021)

Philadelphia, Pennsylvania, United States

Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)

Sioux Falls, South Dakota, United States

University of Texas MD Anderson Cancer Center ( Site 1007)

Houston, Texas, United States

Intermountain - Primary Children's Hospital ( Site 1014)

Salt Lake City, Utah, United States

Sydney Children's Hospital ( Site 1997)

Randwick, New South Wales, Australia

Queensland Children's Hospital-Oncology & Haematology ( Site 1996)

Brisbane, Queensland, Australia

UZ Gent ( Site 1428)

Ghent, Oost-Vlaanderen, Belgium

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)

Curitiba, Paraná, Brazil

Hospital de Clinicas de Porto Alegre ( Site 1265)

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)

São José do Rio Preto, São Paulo, Brazil

McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)

Montreal, Quebec, Canada

Hospital Luis Calvo Mackenna ( Site 1879)

Santiago, Region M. de Santiago, Chile

Hospital Carlos Van Buren ( Site 1880)

Valparaíso, Región de Valparaíso, Chile

Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)

Concepción, Región del Biobío, Chile

Hospital Pablo Tobon Uribe ( Site 1923)

Medellín, Antioquia, Colombia

Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)

Barranquilla, Atlántico, Colombia

IMAT S.A.S ( Site 1921)

Montería, Departamento de Córdoba, Colombia

Detska nemocnice FN Brno ( Site 1388)

Brno, Brno-mesto, Czechia

Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)

Prague, Praha 5, Czechia

Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)

Copenhagen, Capital Region, Denmark

CHU de Bordeaux. Hopital Pellegrin ( Site 1105)

Bordeaux, Aquitaine, France

CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)

Nantes, Pays de la Loire Region, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)

Marseille, Provence-Alpes-Côte d'Azur Region, France

Gustave Roussy ( Site 1103)

Villejuif, Île-de-France Region, France

Universitaetsklinikum Tuebingen ( Site 1142)

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)

Münster, North Rhine-Westphalia, Germany

Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)

Berlin, Germany

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)

Athens, Attica, Greece

Semmelweis Egyetem ( Site 1838)

Budapest, Hungary

Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)

Haifa, Israel

Sheba Medical Center ( Site 1675)

Ramat Gan, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)

Milan, Lombardy, Italy

Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)

Rome, Roma, Italy

Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)

Torino, Italy

Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)

Utrecht, Netherlands

Narodny ustav detskych chorob ( Site 1592)

Bratislava, Bratislava Region, Slovakia

Seoul National University Hospital-Pediatrics ( Site 1972)

Seoul, South Korea

Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)

Seoul, South Korea

Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)

Esplugas de Llobregat, Barcelona, Spain

Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)

Barcelona, Spain

Sahlgrenska Universitetssjukhuset ( Site 1634)

Gothenburg, Västra Götaland County, Sweden

National Taiwan University Hospital ( Site 1983)

Taipei, Taiwan

Ege Universitesi Hastanesi ( Site 1963)

Bornova, İzmir, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 1961)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 1962)

Ankara, Turkey (Türkiye)

Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)

Birmingham, England, United Kingdom

Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)

Newcastle upon Tyne, England, United Kingdom

University College London Hospital ( Site 1350)

London, London, City of, United Kingdom

Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)

Sutton, Surrey, United Kingdom

University Hospital of Wales ( Site 1346)

Cardiff, United Kingdom