RecruitingPhase 1Phase 2NCT06395103

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

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

90 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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

Min Age: 6 MonthsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests zilovertamab vedotin — a targeted drug that attaches to a protein called ROR1 found on cancer cells — in children and young adults with certain cancers that have returned or stopped responding to treatment. **You may be eligible if...** - You are between 1 and 30 years old (specific age range depends on cancer type) - You have been diagnosed with one of the eligible cancers: certain leukemias, lymphomas, sarcomas, or solid tumors that express ROR1 - Your cancer has come back or progressed despite prior treatment - Your organs are functioning well enough for treatment **You may NOT be eligible if...** - Your cancer has spread to the brain in an active/uncontrolled way - You have serious ongoing infections - You have received certain prior treatments within a recent time frame - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALZilovertamab vedotin

Administered via IV infusion

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 Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)

Concepción, Biobio, Chile

Hospital Luis Calvo Mackenna ( Site 1879)

Santiago, Region M. de Santiago, Chile

Hospital Carlos Van Buren ( Site 1880)

Valparaíso, Valparaiso, 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, Loire-Atlantique, 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

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