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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)

NCT ID: NCT06395103

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zilovertamab vedotin

Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Group Type EXPERIMENTAL

Zilovertamab vedotin

Intervention Type BIOLOGICAL

Administered via IV infusion

Interventions

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Zilovertamab vedotin

Administered via IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-2140 VLS-101

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Children's Hospital Los Angeles ( Site 1006)

Los Angeles, California, United States

Site Status RECRUITING

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

Aurora, Colorado, United States

Site Status RECRUITING

Yale-New Haven Hospital ( Site 1012)

New Haven, Connecticut, United States

Site Status RECRUITING

Johns Hopkins All Children's Hospital ( Site 1025)

St. Petersburg, Florida, United States

Site Status RECRUITING

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

Iowa City, Iowa, United States

Site Status RECRUITING

Dana-Farber Cancer Institute ( Site 1013)

Boston, Massachusetts, United States

Site Status RECRUITING

Corewell Health ( Site 1001)

Grand Rapids, Michigan, United States

Site Status RECRUITING

Children's Mercy Hospital ( Site 1024)

Kansas City, Missouri, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 1008)

New Brunswick, New Jersey, United States

Site Status RECRUITING

New York Medical College ( Site 1023)

Valhalla, New York, United States

Site Status RECRUITING

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

Fargo, North Dakota, United States

Site Status RECRUITING

Oregon Health and Science University ( Site 1004)

Portland, Oregon, United States

Site Status RECRUITING

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

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

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

Sioux Falls, South Dakota, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center ( Site 1007)

Houston, Texas, United States

Site Status RECRUITING

Intermountain - Primary Children's Hospital ( Site 1014)

Salt Lake City, Utah, United States

Site Status RECRUITING

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

Randwick, New South Wales, Australia

Site Status RECRUITING

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

Brisbane, Queensland, Australia

Site Status RECRUITING

UZ Gent ( Site 1428)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

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

Curitiba, Paraná, Brazil

Site Status RECRUITING

Hospital de Clinicas de Porto Alegre ( Site 1265)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Barretos, São Paulo, Brazil

Site Status RECRUITING

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

Site Status RECRUITING

McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)

Montreal, Quebec, Canada

Site Status RECRUITING

Hospital Carlos Van Buren ( Site 1880)

Valparaíso, Región de Valparaíso, Chile

Site Status RECRUITING

Hospital Pablo Tobon Uribe ( Site 1923)

Medellín, Antioquia, Colombia

Site Status RECRUITING

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

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

IMAT S.A.S ( Site 1921)

Montería, Departamento de Córdoba, Colombia

Site Status RECRUITING

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

Prague, Praha 5, Czechia

Site Status RECRUITING

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

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

CHU de Bordeaux. Hopital Pellegrin ( Site 1105)

Bordeaux, Aquitaine, France

Site Status RECRUITING

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

Lyon, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

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

Nantes, Pays de la Loire Region, France

Site Status RECRUITING

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

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

Site Status RECRUITING

Gustave Roussy ( Site 1103)

Villejuif, Île-de-France Region, France

Site Status RECRUITING

Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

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

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

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

Berlin, , Germany

Site Status RECRUITING

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

Athens, Attica, Greece

Site Status RECRUITING

Semmelweis Egyetem ( Site 1838)

Budapest, , Hungary

Site Status RECRUITING

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

Haifa, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 1675)

Ramat Gan, , Israel

Site Status RECRUITING

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

Milan, Lombardy, Italy

Site Status RECRUITING

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

Rome, Roma, Italy

Site Status RECRUITING

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

Torino, , Italy

Site Status RECRUITING

Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)

Utrecht, , Netherlands

Site Status RECRUITING

Narodny ustav detskych chorob ( Site 1592)

Bratislava, Bratislava Region, Slovakia

Site Status RECRUITING

Seoul National University Hospital-Pediatrics ( Site 1972)

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

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

Esplugas de Llobregat, Barcelona, Spain

Site Status RECRUITING

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

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

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

Barcelona, , Spain

Site Status RECRUITING

Prövningsenhet barn, Sahlgrenska Universitetssjukhuset ( Site 1634)

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

National Taiwan University Hospital ( Site 1983)

Taipei, , Taiwan

Site Status RECRUITING

Hacettepe Universite Hastaneleri ( Site 1961)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent Şehir Hastanesi ( Site 1962)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ege Universitesi Hastanesi ( Site 1963)

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

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

Newcastle upon Tyne, England, United Kingdom

Site Status RECRUITING

University College London Hospital ( Site 1350)

London, London, City of, United Kingdom

Site Status RECRUITING

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

Sutton, Surrey, United Kingdom

Site Status RECRUITING

University Hospital of Wales ( Site 1346)

Cardiff, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Brazil Canada Chile Colombia Czechia Denmark France Germany Greece Hungary Israel Italy Netherlands Slovakia South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26269&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

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MK-9999-01A

Identifier Type: OTHER

Identifier Source: secondary_id

LIGHTBEAM-U01

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507178-41-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1295-3459

Identifier Type: REGISTRY

Identifier Source: secondary_id

9999-01A

Identifier Type: -

Identifier Source: org_study_id