What this study is
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.
What's being tested
- Zilovertamab vedotin
Intervention · BIOLOGICAL
Administered via IV infusion
Study details
- 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
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- B-cell Acute Lymphoblastic Leukemia · Diffuse Large B-cell Lymphoma · Burkitt Lymphoma · Neuroblastoma · Ewing Sarcoma
- Enrolling
- 90 people
- Starts
- 2024-08-16
- Est. completion
- 2029-03-31
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Months – 25 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (71)
70 openChildren's Hospital Los Angeles ( Site 1006)
Los Angeles, California, United States
- Study Coordinator · Contact323-361-2121
RecruitingChildren's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
Aurora, Colorado, United States
- Study Coordinator · Contact720-777-1234
RecruitingYale New Haven Hospital ( Site 1012)
New Haven, Connecticut, United States
- Study Coordinator · Contact203-785-4640
RecruitingJohns Hopkins All Children's Hospital ( Site 1025)
St. Petersburg, Florida, United States
- Study Coordinator · Contact727-767-4176
RecruitingUniversity of Iowa Health Care. ( Site 1017)
Iowa City, Iowa, United States
- Study Coordinator · Contact319-356-2577
RecruitingDana-Farber Cancer Institute ( Site 1013)
Boston, Massachusetts, United States
- Study Coordinator · Contact617-632-4580
RecruitingCorewell Health ( Site 1001)
Grand Rapids, Michigan, United States
- Study Coordinator · Contact616-486-0746
RecruitingChildren's Mercy Hospital ( Site 1024)
Kansas City, Missouri, United States
- Study Coordinator · Contact816-302-6808
RecruitingRutgers Cancer Institute of New Jersey ( Site 1008)
New Brunswick, New Jersey, United States
- Study Coordinator · Contact732-235-2465
RecruitingMemorial Sloan Kettering Cancer Center ( Site 1010)
New York, New York, United States
- Study Coordinator · Contact888-492-8401
RecruitingNew York Medical College ( Site 1023)
Valhalla, New York, United States
- Study Coordinator · Contact914-614-4270
RecruitingSanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
Fargo, North Dakota, United States
- Study Coordinator · Contact701-234-2000
RecruitingOregon Health and Science University ( Site 1004)
Portland, Oregon, United States
- Study Coordinator · Contact503-494-8311
RecruitingChildren's Hospital of Philadelphia (CHOP) ( Site 1021)
Philadelphia, Pennsylvania, United States
- Study Coordinator · Contact267-425-5544
RecruitingSanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
Sioux Falls, South Dakota, United States
- Study Coordinator · Contact605-312-1000
RecruitingUniversity of Texas MD Anderson Cancer Center ( Site 1007)
Houston, Texas, United States
- Study Coordinator · Contact713-792-5410
RecruitingIntermountain - Primary Children's Hospital ( Site 1014)
Salt Lake City, Utah, United States
- Study Coordinator · Contact801-662-4700
Recruiting
54 sites outside the US
Sydney Children's Hospital ( Site 1997)
Randwick, New South Wales, Australia
- Study Coordinator · Contact61293821111
RecruitingQueensland Children's Hospital-Oncology & Haematology ( Site 1996)
Brisbane, Queensland, Australia
- Study Coordinator · Contact61730681111
RecruitingRoyal Children's Hospital-Children's Cancer Centre ( Site 1994)
Melbourne, Victoria, Australia
- Study Coordinator · Contact61393455522
Recruiting- Recruiting
Hospital de Clinicas de Porto Alegre ( Site 1265)
Porto Alegre, Rio Grande do Sul, Brazil
- Study Coordinator · Contact+5551980139616
RecruitingFundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
Barretos, São Paulo, Brazil
- Study Coordinator · Contact+551733216638
RecruitingFundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)
São José do Rio Preto, São Paulo, Brazil
- Study Coordinator · Contact+55 17 3201-5054
RecruitingAlberta Children's Hospital ( Site 1227)
Calgary, Alberta, Canada
- Study Coordinator · Contact403-955-7211
RecruitingThe Hospital for Sick Children ( Site 1225)
Toronto, Ontario, Canada
- Study Coordinator · Contact416-813-1500
RecruitingMcGill University Health Centre-Pediatric HematologyOncology ( Site 1223)
Montreal, Quebec, Canada
- Study Coordinator · Contact514-412-4445
RecruitingHospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)
Concepción, Biobio, Chile
- Study Coordinator · Contact+56994992198
RecruitingHospital Luis Calvo Mackenna ( Site 1879)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact+56994992198
RecruitingHospital Carlos Van Buren ( Site 1880)
Valparaíso, Valparaiso, Chile
- Study Coordinator · Contact56978546125
RecruitingHospital Pablo Tobon Uribe ( Site 1923)
Medellín, Antioquia, Colombia
- Study Coordinator · Contact+57 3006523572
RecruitingClinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)
Barranquilla, Atlántico, Colombia
- Study Coordinator · Contact+573008096054
RecruitingIMAT S.A.S ( Site 1921)
Montería, Departamento de Córdoba, Colombia
- Study Coordinator · Contact57317 3727618
RecruitingDetska nemocnice FN Brno ( Site 1388)
Brno, Brno-mesto, Czechia
- Study Coordinator · Contact+420532234755
RecruitingFakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)
Prague, Praha 5, Czechia
- Study Coordinator · Contact+420224436475
RecruitingRigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)
Copenhagen, Capital Region, Denmark
- Study Coordinator · Contact+4535452462
RecruitingCHU de Bordeaux. Hopital Pellegrin ( Site 1105)
Bordeaux, Aquitaine, France
- Study Coordinator · Contact+33556795679
RecruitingCENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)
Lyon, Auvergne-Rhône-Alpes, France
- Study Coordinator · Contact33469166572
RecruitingCentre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)
Nantes, Loire-Atlantique, France
- Study Coordinator · Contact33240083610
RecruitingAssistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)
Marseille, Provence-Alpes-Côte d'Azur Region, France
- Study Coordinator · Contact33491386821
RecruitingGustave Roussy ( Site 1103)
Villejuif, Île-de-France Region, France
- Study Coordinator · Contact+33142114211
RecruitingUniversitaetsklinikum Tuebingen ( Site 1142)
Tübingen, Baden-Wurttemberg, Germany
- Study Coordinator · Contact+4970712983781
RecruitingUniversitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)
Cologne, North Rhine-Westphalia, Germany
- Study Coordinator · Contact0049221 478 6831
RecruitingUniversitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)
Münster, North Rhine-Westphalia, Germany
- Study Coordinator · Contact+492518347742
RecruitingCharité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)
Berlin, Germany
- Study Coordinator · Contact+4930 45050
RecruitingAghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)
Athens, Attica, Greece
- Study Coordinator · Contact+302107452125
Recruiting- Recruiting
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
Haifa, Israel
- Study Coordinator · Contact97247774718
Recruiting- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)
Milan, Lombardy, Italy
- Study Coordinator · Contact00390223902593
RecruitingOspedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)
Rome, Roma, Italy
- Study Coordinator · Contact+39 06 68592377
RecruitingOspedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)
Torino, Italy
- Study Coordinator · Contact00390113135230
RecruitingPrinses Maxima Centrum voor Kinderoncologie ( Site 1510)
Utrecht, Netherlands
- Study Coordinator · Contact+31889729529
RecruitingNarodny ustav detskych chorob ( Site 1592)
Bratislava, Bratislava Region, Slovakia
- Study Coordinator · Contact+421259371205
RecruitingSeoul National University Hospital-Pediatrics ( Site 1972)
Seoul, South Korea
- Study Coordinator · Contact+82220723304
RecruitingAsan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
Seoul, South Korea
- Study Coordinator · Contact+82230105994
RecruitingHospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)
Esplugas de Llobregat, Barcelona, Spain
- Study Coordinator · Contact34 93.600.97.33
RecruitingHospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)
Madrid, Madrid, Comunidad de, Spain
- Study Coordinator · Contact+34913875000
RecruitingHospital Universitario y Politecnico La Fe de Valencia ( Site 1718)
Valencia, Valenciana, Comunitat, Spain
- Study Coordinator · Contact+34961244000x490871
RecruitingHospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)
Barcelona, Spain
- Study Coordinator · Contact34934893093
RecruitingSahlgrenska Universitetssjukhuset ( Site 1634)
Gothenburg, Västra Götaland County, Sweden
- Study Coordinator · Contact+46313436655
RecruitingNational Taiwan University Hospital ( Site 1983)
Taipei, Taiwan
- Study Coordinator · Contact8862-23123456#70559
RecruitingEge Universitesi Hastanesi ( Site 1963)
Bornova, İzmir, Turkey (Türkiye)
- Study Coordinator · Contact+90 232 390 43 87
RecruitingHacettepe Universite Hastaneleri ( Site 1961)
Ankara, Turkey (Türkiye)
- Study Coordinator · Contact+90 312 305 50 00
RecruitingAnkara Bilkent Şehir Hastanesi ( Site 1962)
Ankara, Turkey (Türkiye)
- Study Coordinator · Contact+90 312 552 60 00
RecruitingBirmingham Children's Hospital-Oncology/Haematology ( Site 1349)
Birmingham, England, United Kingdom
- Study Coordinator · Contact+441213338233
RecruitingRoyal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
Newcastle upon Tyne, England, United Kingdom
- Study Coordinator · Contact0191 282 1014
RecruitingUniversity College London Hospital ( Site 1350)
London, London, City of, United Kingdom
- Study Coordinator · Contact02034472485
RecruitingRoyal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
Sutton, Surrey, United Kingdom
- Study Coordinator · Contact020 8642 6011
RecruitingUniversity Hospital of Wales ( Site 1346)
Cardiff, United Kingdom
- Study Coordinator · Contact+4402921842107
RecruitingHospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
Curitiba, Paraná, Brazil
Completed
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 9999-01A
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.