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

Last updated: May 28, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Hematologic Cancer

Neuroblastoma

Hematologic Neoplasms

Treatment

Zilovertamab vedotin

Clinical Study ID

NCT06395103
9999-01A
U1111-1295-3459
MK-9999-01A
2023-507178-41
LIGHTBEAM-U01
  • Ages 6-25
  • All Genders

Study 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 Criteria

Inclusion

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 orDLBCL/Burkitt lymphoma according to World Health Organization (WHO) classificationof neoplasms of the lymphoid tissues.

  • For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma orEwing sarcoma.

Exclusion

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 GVHDtreatment 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 prednisoneequivalent). Prednisone equivalent dosing must have been stable for at least 4 weeksbefore Cycle 1 Day 1 (C1D1).

  • Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strongCYP3A4 inducer within 14 days before the start of study intervention or expectedrequirement for chronic use of a strong CYP3A4 inhibitor or inducer during the studyintervention period and for 30 days after the last dose of study intervention

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention (except for prophylacticintrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.

  • Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention. Administration of killed vaccines is allowed.

  • Has received an investigational agent or has used an investigational device within 4weeks prior to study intervention administration.

  • Known additional malignancy that is progressing or has required active treatmentwithin 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 ongoingsurgical complications.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Zilovertamab vedotin
Phase: 1/2
Study Start date:
August 16, 2024
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Sydney Children's Hospital-Kids Cancer Centre ( Site 1997)

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

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

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • UZ Gent ( Site 1428)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

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

    Curitiba, Parana 81520-060
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre ( Site 1265)

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Active - Recruiting

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

    Barretos, Sao Paulo 14784400
    Brazil

    Active - Recruiting

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

    São José do Rio Preto, Sao Paulo 15090000
    Brazil

    Active - Recruiting

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

    São José do Rio Preto, Sao Paulo 15090000
    Brazil

    Active - Recruiting

  • Hospital Carlos Van Buren ( Site 1880)

    Valparaíso, Valparaiso 2341131
    Chile

    Active - Recruiting

  • Hospital Pablo Tobon Uribe ( Site 1923)

    Medellin, Antioquia 050034
    Colombia

    Active - Recruiting

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

    Barranquilla, Atlantico 080020
    Colombia

    Active - Recruiting

  • IMAT S.A.S ( Site 1921)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 14

    Copenhagen, Hovedstaden DK-2100
    Denmark

    Active - Recruiting

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

    Copenhagen, Hovedstaden DK-2100
    Denmark

    Active - Recruiting

  • CHU de Bordeaux. Hopital Pellegrin ( Site 1105)

    Bordeaux, Aquitaine 33076
    France

    Active - Recruiting

  • Gustave Roussy ( Site 1103)

    Villejuif, Ile-de-France 94805
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 11

    Nantes, Pays-de-la-Loire 44093
    France

    Active - Recruiting

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

    Nantes, Pays-de-la-Loire 44093
    France

    Active - Recruiting

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

    Lyon, Rhone-Alpes 69373
    France

    Active - Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit

    Münster, Nordrhein-Westfalen 48149
    Germany

    Active - Recruiting

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

    Münster, Nordrhein-Westfalen 48149
    Germany

    Active - Recruiting

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

    Athens, Attiki 115 27
    Greece

    Active - Recruiting

  • Semmelweis Egyetem ( Site 1838)

    Budapest, 1085
    Hungary

    Active - Recruiting

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

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 1675)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

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

    Milan, Lombardia 20133
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

    Rome, Roma 00165
    Italy

    Active - Recruiting

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

    Rome, Roma 00165
    Italy

    Active - Recruiting

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

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital-Pediatrics ( Site 1972)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)

    Utrecht, 3584 CS
    Netherlands

    Active - Recruiting

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

    Esplugas De Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

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

    Madrid, Madrid, Comunidad De 28009
    Spain

    Active - Recruiting

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

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Prövningsenhet barn, Sahlgrenska Universitetssjukhuset ( Site 1634)

    Gothenburg, Vastra Gotalands Lan 416 85
    Sweden

    Active - Recruiting

  • National Taiwan University Hospital ( Site 1983)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 1962)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1961)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Ege Universitesi Hastanesi ( Site 1963)

    İzmir, 35100
    Turkey

    Active - Recruiting

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

    Newcastle upon Tyne, England NE1 4PL
    United Kingdom

    Active - Recruiting

  • University College London Hospital ( Site 1350)

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales ( Site 1346)

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Children's Hospital Los Angeles ( Site 1006)

    Los Angeles, California 90027
    United States

    Active - Recruiting

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

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale-New Haven Hospital ( Site 1012)

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Johns Hopkins All Children's Hospital ( Site 1025)

    Saint Petersburg, Florida 33701
    United States

    Active - Recruiting

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

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute ( Site 1013)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Corewell Health ( Site 1001)

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Children's Mercy Hospital ( Site 1024)

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 1008)

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • New York Medical College ( Site 1023)

    Valhalla, New York 10595
    United States

    Active - Recruiting

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

    Fargo, North Dakota 58122
    United States

    Active - Recruiting

  • Oregon Health and Science University ( Site 1004)

    Portland, Oregon 97239
    United States

    Active - Recruiting

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

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center ( Site 1007)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Intermountain - Primary Children's Hospital ( Site 1014)

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

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