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

May 29, 2026 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Sydney Children's Hospital ( Site 1997)
        • Contact:
          • Study Coordinator
          • Phone Number: 61293821111
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland Children's Hospital-Oncology & Haematology ( Site 1996)
        • Contact:
          • Study Coordinator
          • Phone Number: 61730681111
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital-Children's Cancer Centre ( Site 1994)
        • Contact:
          • Study Coordinator
          • Phone Number: 61393455522
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 1428)
        • Contact:
          • Study Coordinator
          • Phone Number: +3293320295
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Completed
        • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre ( Site 1265)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551980139616
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216638
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 17 3201-5054
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children ( Site 1225)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-813-1500
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-412-4445
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070038
        • Recruiting
        • Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)
        • Contact:
          • Study Coordinator
          • Phone Number: +56994992198
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500539
        • Recruiting
        • Hospital Luis Calvo Mackenna ( Site 1879)
        • Contact:
          • Study Coordinator
          • Phone Number: +56994992198
    • Valparaiso
      • Valparaíso, Valparaiso, Chile, 2341131
        • Recruiting
        • Hospital Carlos Van Buren ( Site 1880)
        • Contact:
          • Study Coordinator
          • Phone Number: 56978546125
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Recruiting
        • Hospital Pablo Tobon Uribe ( Site 1923)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3006523572
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Recruiting
        • Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)
        • Contact:
          • Study Coordinator
          • Phone Number: +573008096054
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 1921)
        • Contact:
          • Study Coordinator
          • Phone Number: 57317 3727618
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno ( Site 1388)
        • Contact:
          • Study Coordinator
          • Phone Number: +420532234755
    • Praha 5
      • Prague, Praha 5, Czechia, 150 00
        • Recruiting
        • Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224436475
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)
        • Contact:
          • Study Coordinator
          • Phone Number: +4535452462
  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • CHU de Bordeaux. Hopital Pellegrin ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556795679
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69373
        • Recruiting
        • CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 33469166572
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: 33240083610
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 33491386821
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Recruiting
        • Gustave Roussy ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142114211
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930 45050
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen ( Site 1142)
        • Contact:
          • Study Coordinator
          • Phone Number: +4970712983781
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049221 478 6831
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)
        • Contact:
          • Study Coordinator
          • Phone Number: +492518347742
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107452125
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem ( Site 1838)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612151380
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
        • Contact:
          • Study Coordinator
          • Phone Number: 97247774718
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1675)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235302996
  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390113135230
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390223902593
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 06 68592377
  • Netherlands
      • Utrecht, Netherlands, 3584 CS
        • Recruiting
        • Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +31889729529
  • Slovakia
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 831 01
        • Recruiting
        • Narodny ustav detskych chorob ( Site 1592)
        • Contact:
          • Study Coordinator
          • Phone Number: +421259371205
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital-Pediatrics ( Site 1972)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220723304
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230105994
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)
        • Contact:
          • Study Coordinator
          • Phone Number: 34934893093
    • Barcelona
      • Esplugas de Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 93.600.97.33
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913875000
  • Sweden
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 416 85
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 1634)
        • Contact:
          • Study Coordinator
          • Phone Number: +46313436655
  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital ( Site 1983)
        • Contact:
          • Study Coordinator
          • Phone Number: 8862-23123456#70559
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1961)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 305 50 00
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi ( Site 1962)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 552 60 00
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 1963)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 232 390 43 87
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales ( Site 1346)
        • Contact:
          • Study Coordinator
          • Phone Number: +4402921842107
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)
        • Contact:
          • Study Coordinator
          • Phone Number: +441213338233
      • Newcastle upon Tyne, England, United Kingdom, NE1 4PL
        • Recruiting
        • Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
        • Contact:
          • Study Coordinator
          • Phone Number: 0191 282 1014
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 1350)
        • Contact:
          • Study Coordinator
          • Phone Number: 02034472485
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 8642 6011
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: 323-361-2121
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-777-1234
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital ( Site 1012)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-785-4640
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital ( Site 1025)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-767-4176
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2296
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute ( Site 1013)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-4580
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-486-0746
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital ( Site 1024)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-302-6808
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-235-2465
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 1010)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-492-8401
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College ( Site 1023)
        • Contact:
          • Study Coordinator
          • Phone Number: 914-614-4270
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-2000
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-494-8311
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia (CHOP) ( Site 1021)
        • Contact:
          • Study Coordinator
          • Phone Number: 267-425-5544
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-312-1000
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-5410
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Intermountain - Primary Children's Hospital ( Site 1014)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-662-4700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zilovertamab vedotin
Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).
Biological: Zilovertamab vedotin
Administered via IV infusion
Other Names:
  • MK-2140
  • VLS-101

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
Time Frame: Up to 42 days
Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose.
Up to 42 days
Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who experience at least 1 AE will be presented.
Up to approximately 54 months
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
Up to approximately 54 months
Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who receive a dose modification due to an AE will be presented.
Up to approximately 54 months
Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Time Frame: Up to approximately 54 months
OR for participants with B-ALL is defined as complete response (CR) or complete response with incomplete hematologic recovery (CRi) based on investigator's assessment per Ponte-di-Legno Consortium criteria. For Part 1 and Part 2, the OR for participants with B-ALL as assessed by investigator will be presented.
Up to approximately 54 months
Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma
Time Frame: Up to approximately 54 months
OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma is defined as complete response (CR) or partial response (PR) based on investigator's assessment per International Pediatric Non-Hodgkin Lymphoma (IPNHL) Response Criteria for participants with DLBCL/Burkitt lymphoma, per International Neuroblastoma Response Criteria (INRC) for neuroblastoma, and per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Ewing sarcoma. For Part 1 and Part 2, the OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma as assessed by investigator will be presented.
Up to approximately 54 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the AUC of total antibody.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Cmax of total antibody.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Ctrough of total antibody.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the t1/2 of total antibody.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC)
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the AUC of ADC.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Cmax of ADC
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Cmax of ADC.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Ctrough of ADC
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Ctrough of ADC.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: t1/2 of ADC
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the t1/2 of ADC.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE)
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the AUC of MMAE.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Cmax of MMAE
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Cmax of MMAE.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Ctrough of MMAE
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the Ctrough of MMAE.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: t1/2 of MMAE
Time Frame: Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated time points will be used to determine the t1/2 of MMAE.
Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months)
Part 2: Number of Participants Who Experience One or More AEs
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who experience at least 1 AE will be presented.
Up to approximately 54 months
Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who discontinue study treatment due to an AE will be presented.
Up to approximately 54 months
Part 2: Number of Participants Who Receive Dose Modification Due to AEs
Time Frame: Up to approximately 54 months
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who receive a dose modification due to an AE will be presented.
Up to approximately 54 months
Part 1 and Part 2: Incidence of Antidrug Antibodies (ADAs) to Zilovertamab Vedotin
Time Frame: Predose on Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 4 cycles thereafter. Each cycle is 21 days. (Up to approximately 54 months)
Blood samples collected at designated timepoints will be used to determine the ADA response to zilovertamab vedotin. The incidence of ADAs over time will be presented.
Predose on Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 4 cycles thereafter. Each cycle is 21 days. (Up to approximately 54 months)
Part 1 and Part 2: Duration of Response (DOR)
Time Frame: Up to approximately 54 months
DOR is defined as the time from the first documented evidence of CR/CRi for B-ALL or CR/PR for DLBCL/Burkitt lymphoma, Ewing sarcoma, and neuroblastoma until disease progression or death due to any cause, whichever occurs first. For participants under 1-year of age, the time from the first dose will start from the first dose a participant receives during Part 2.
Up to approximately 54 months
Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT)
Time Frame: Up to approximately 54 months
The percentage of participants with DLBCL/Burkitt Lymphoma who go on to receive SCT will be presented.
Up to approximately 54 months
Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT
Time Frame: Up to approximately 54 months
The percentage of participants with B-ALL who go on to receive SCT will be presented.
Up to approximately 54 months
Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T)
Time Frame: Up to approximately 54 months
The percentage of participants with B-ALL who go on to receive CAR-T will be presented.
Up to approximately 54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9999-01A
  • LIGHTBEAM-U01 (Other Identifier: MSD)
  • MK-9999-01A (Other Identifier: MSD)
  • U1111-1295-3459 (Registry Identifier: UTN)
  • 2023-507178-41-00 (Registry Identifier: EU CT)
  • jRCT2031250824 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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