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B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT06395103

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

A Phase 1/2 study testing Zilovertamab vedotin in people with B-cell Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma, run by Merck Sharp & Dohme LLC at 71 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 25 years
What is being tested?
Zilovertamab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
71 sitesin 23 countries
Study dates
16 Aug 2024to 31 Mar 2029
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

71 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

71 sites in 23 countries

United States17 sites, 17 recruiting

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

    Aurora, Colorado, 80045

    Study Coordinator, 720-777-1234

    Recruiting

  • Dana-Farber Cancer Institute ( Site 1013)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-4580

    Recruiting

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

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-2000

    Recruiting

  • Corewell Health ( Site 1001)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-486-0746

    Recruiting

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

    Houston, Texas, 77030

    Study Coordinator, 713-792-5410

    Recruiting

  • University of Iowa Health Care. ( Site 1017)

    Iowa City, Iowa, 52242

    Study Coordinator, 319-356-2577

    Recruiting

  • Children's Mercy Hospital ( Site 1024)

    Kansas City, Missouri, 64108

    Study Coordinator, 816-302-6808

    Recruiting

  • Children's Hospital Los Angeles ( Site 1006)

    Los Angeles, California, 90027

    Study Coordinator, 323-361-2121

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 1008)

    New Brunswick, New Jersey, 08903

    Study Coordinator, 732-235-2465

    Recruiting

  • Yale New Haven Hospital ( Site 1012)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-785-4640

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 1010)

    New York, New York, 10065

    Study Coordinator, 888-492-8401

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 267-425-5544

    Recruiting

  • Oregon Health and Science University ( Site 1004)

    Portland, Oregon, 97239

    Study Coordinator, 503-494-8311

    Recruiting

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

    Salt Lake City, Utah, 84113

    Study Coordinator, 801-662-4700

    Recruiting

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

    Sioux Falls, South Dakota, 57105

    Study Coordinator, 605-312-1000

    Recruiting

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

    St. Petersburg, Florida, 33701

    Study Coordinator, 727-767-4176

    Recruiting

  • New York Medical College ( Site 1023)

    Valhalla, New York, 10595

    Study Coordinator, 914-614-4270

    Recruiting

Other trials in United States

France5 sites, 5 recruiting

  • CHU de Bordeaux. Hopital Pellegrin ( Site 1105)

    Bordeaux, Aquitaine, 33076

    Study Coordinator, +33556795679

    Recruiting

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

    Lyon, Auvergne-Rhône-Alpes, 69373

    Study Coordinator, 33469166572

    Recruiting

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

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

    Study Coordinator, 33491386821

    Recruiting

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

    Nantes, Loire-Atlantique, 44093

    Study Coordinator, 33240083610

    Recruiting

  • Gustave Roussy ( Site 1103)

    Villejuif, Île-de-France Region, 94805

    Study Coordinator, +33142114211

    Recruiting

Other trials in France

United Kingdom5 sites, 5 recruiting

  • Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)

    Birmingham, England, B4 6NH

    Study Coordinator, +441213338233

    Recruiting

  • University Hospital of Wales ( Site 1346)

    Cardiff, CF14 4XW

    Study Coordinator, +4402921842107

    Recruiting

  • University College London Hospital ( Site 1350)

    London, London, City of, NW1 2PG

    Study Coordinator, 02034472485

    Recruiting

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

    Newcastle upon Tyne, England, NE1 4PL

    Study Coordinator, 0191 282 1014

    Recruiting

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

    Sutton, Surrey, SM2 5PT

    Study Coordinator, 020 8642 6011

    Recruiting

Other trials in United Kingdom

Brazil4 sites, 3 recruiting

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

    Barretos, São Paulo, 14784400

    Study Coordinator, +551733216638

    Recruiting

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

    Curitiba, Paraná, 81520-060

    Completed

  • Hospital de Clinicas de Porto Alegre ( Site 1265)

    Porto Alegre, Rio Grande do Sul, 90035-903

    Study Coordinator, +5551980139616

    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, 15090000

    Study Coordinator, +55 17 3201-5054

    Recruiting

Other trials in Brazil

Germany4 sites, 4 recruiting

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

    Berlin, 13353

    Study Coordinator, +4930 45050

    Recruiting

  • Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)

    Cologne, North Rhine-Westphalia, 50937

    Study Coordinator, 0049221 478 6831

    Recruiting

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

    Münster, North Rhine-Westphalia, 48149

    Study Coordinator, +492518347742

    Recruiting

  • Universitaetsklinikum Tuebingen ( Site 1142)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, +4970712983781

    Recruiting

Other trials in Germany

Spain4 sites, 4 recruiting

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

    Barcelona, 08035

    Study Coordinator, 34934893093

    Recruiting

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

    Esplugas de Llobregat, Barcelona, 08950

    Study Coordinator, 34 93.600.97.33

    Recruiting

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

    Madrid, Madrid, Comunidad de, 28009

    Study Coordinator, +34913875000

    Recruiting

  • Hospital Universitario y Politecnico La Fe de Valencia ( Site 1718)

    Valencia, Valenciana, Comunitat, 46026

    Study Coordinator, +34961244000x490871

    Recruiting

Other trials in Spain

Australia3 sites, 3 recruiting

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

    Brisbane, Queensland, 4101

    Study Coordinator, 61730681111

    Recruiting

  • Royal Children's Hospital-Children's Cancer Centre ( Site 1994)

    Melbourne, Victoria, 3052

    Study Coordinator, 61393455522

    Recruiting

  • Sydney Children's Hospital ( Site 1997)

    Randwick, New South Wales, 2031

    Study Coordinator, 61293821111

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • Alberta Children's Hospital ( Site 1227)

    Calgary, Alberta, T3B 6A8

    Study Coordinator, 403-955-7211

    Recruiting

  • McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 514-412-4445

    Recruiting

  • The Hospital for Sick Children ( Site 1225)

    Toronto, Ontario, M5G 1X8

    Study Coordinator, 416-813-1500

    Recruiting

Other trials in Canada

Chile3 sites, 3 recruiting

  • Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)

    Concepción, Biobio, 4070038

    Study Coordinator, +56994992198

    Recruiting

  • Hospital Luis Calvo Mackenna ( Site 1879)

    Santiago, Region M. de Santiago, 7500539

    Study Coordinator, +56994992198

    Recruiting

  • Hospital Carlos Van Buren ( Site 1880)

    Valparaíso, Valparaiso, 2341131

    Study Coordinator, 56978546125

    Recruiting

Other trials in Chile

Colombia3 sites, 3 recruiting

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

    Barranquilla, Atlántico, 080020

    Study Coordinator, +573008096054

    Recruiting

  • Hospital Pablo Tobon Uribe ( Site 1923)

    Medellín, Antioquia, 050034

    Study Coordinator, +57 3006523572

    Recruiting

  • IMAT S.A.S ( Site 1921)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, 57317 3727618

    Recruiting

Other trials in Colombia

Italy3 sites, 3 recruiting

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

    Milan, Lombardy, 20133

    Study Coordinator, 00390223902593

    Recruiting

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

    Rome, Roma, 00165

    Study Coordinator, +39 06 68592377

    Recruiting

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

    Torino, 10126

    Study Coordinator, 00390113135230

    Recruiting

Other trials in Italy

Turkey (Türkiye)3 sites, 3 recruiting

  • Hacettepe Universite Hastaneleri ( Site 1961)

    Ankara, 06230

    Study Coordinator, +90 312 305 50 00

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 1962)

    Ankara, 06800

    Study Coordinator, +90 312 552 60 00

    Recruiting

  • Ege Universitesi Hastanesi ( Site 1963)

    Bornova, İzmir, 35100

    Study Coordinator, +90 232 390 43 87

    Recruiting

Other trials in Turkey (Türkiye)

Czechia2 sites, 2 recruiting

  • Detska nemocnice FN Brno ( Site 1388)

    Brno, Brno-mesto, 613 00

    Study Coordinator, +420532234755

    Recruiting

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

    Prague, Praha 5, 150 00

    Study Coordinator, +420224436475

    Recruiting

Other trials in Czechia

Israel2 sites, 2 recruiting

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

    Haifa, 3109601

    Study Coordinator, 97247774718

    Recruiting

  • Sheba Medical Center ( Site 1675)

    Ramat Gan, 5265601

    Study Coordinator, +97235302996

    Recruiting

Other trials in Israel

South Korea2 sites, 2 recruiting

  • Seoul National University Hospital-Pediatrics ( Site 1972)

    Seoul, 03080

    Study Coordinator, +82220723304

    Recruiting

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

    Seoul, 05505

    Study Coordinator, +82230105994

    Recruiting

Other trials in South Korea

Belgium1 site, 1 recruiting

  • UZ Gent ( Site 1428)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3293320295

    Recruiting

Other trials in Belgium

Denmark1 site, 1 recruiting

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

    Copenhagen, Capital Region, DK-2100

    Study Coordinator, +4535452462

    Recruiting

Other trials in Denmark

Greece1 site, 1 recruiting

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

    Athens, Attica, 115 27

    Study Coordinator, +302107452125

    Recruiting

Other trials in Greece

Hungary1 site, 1 recruiting

  • Semmelweis Egyetem ( Site 1838)

    Budapest, 1085

    Study Coordinator, +3612151380

    Recruiting

Other trials in Hungary

Netherlands1 site, 1 recruiting

  • Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)

    Utrecht, 3584 CS

    Study Coordinator, +31889729529

    Recruiting

Other trials in Netherlands

Slovakia1 site, 1 recruiting

  • Narodny ustav detskych chorob ( Site 1592)

    Bratislava, Bratislava Region, 833 40

    Study Coordinator, +421259371205

    Recruiting

Other trials in Slovakia

Sweden1 site, 1 recruiting

  • Sahlgrenska Universitetssjukhuset ( Site 1634)

    Gothenburg, Västra Götaland County, 416 85

    Study Coordinator, +46313436655

    Recruiting

Other trials in Sweden

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital ( Site 1983)

    Taipei, 10002

    Study Coordinator, 8862-23123456#70559

    Recruiting

Other trials in Taiwan

About this study

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

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.

Being tested
Zilovertamab vedotin
Medical subject headings
Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Neuroblastoma, Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinBiological

    Also called MK-2140, VLS-101

    Administered via IV infusion

Study groups in NCT06395103
Study groupRoleWhat they receive
Zilovertamab vedotinExperimentalParticipants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).
Receives: Biological: Zilovertamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)

    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.

    Measured: Up to 42 days

  2. Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)

    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.

    Measured: Up to approximately 54 months

  3. Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs

    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.

    Measured: Up to approximately 54 months

  4. Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs

    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.

    Measured: Up to approximately 54 months

  5. Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

    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.

    Measured: Up to approximately 54 months

  6. Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma

    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.

    Measured: Up to approximately 54 months

Secondary outcomes (20)

  1. Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody

    Blood samples collected at designated time points will be used to determine the AUC of total antibody.

    Measured: 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)

  2. Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody

    Blood samples collected at designated time points will be used to determine the Cmax of total antibody.

    Measured: 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)

  3. Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody

    Blood samples collected at designated time points will be used to determine the Ctrough of total antibody.

    Measured: 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)

  4. Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody

    Blood samples collected at designated time points will be used to determine the t1/2 of total antibody.

    Measured: 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)

  5. Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC)

    Blood samples collected at designated time points will be used to determine the AUC of ADC.

    Measured: 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)

  6. Part 1 and Part 2: Cmax of ADC

    Blood samples collected at designated time points will be used to determine the Cmax of ADC.

    Measured: 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)

  7. Part 1 and Part 2: Ctrough of ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of ADC.

    Measured: 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)

  8. Part 1 and Part 2: t1/2 of ADC

    Blood samples collected at designated time points will be used to determine the t1/2 of ADC.

    Measured: 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)

  9. Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE)

    Blood samples collected at designated time points will be used to determine the AUC of MMAE.

    Measured: 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)

  10. Part 1 and Part 2: Cmax of MMAE

    Blood samples collected at designated time points will be used to determine the Cmax of MMAE.

    Measured: 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)

  11. Part 1 and Part 2: Ctrough of MMAE

    Blood samples collected at designated time points will be used to determine the Ctrough of MMAE.

    Measured: 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)

  12. Part 1 and Part 2: t1/2 of MMAE

    Blood samples collected at designated time points will be used to determine the t1/2 of MMAE.

    Measured: 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)

  13. Part 2: Number of Participants Who Experience One or More AEs

    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.

    Measured: Up to approximately 54 months

  14. Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs

    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.

    Measured: Up to approximately 54 months

  15. Part 2: Number of Participants Who Receive Dose Modification Due to AEs

    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.

    Measured: Up to approximately 54 months

  16. Part 1 and Part 2: Incidence of Antidrug Antibodies (ADAs) to Zilovertamab Vedotin

    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.

    Measured: 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)

  17. Part 1 and Part 2: Duration of Response (DOR)

    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.

    Measured: Up to approximately 54 months

  18. Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT)

    The percentage of participants with DLBCL/Burkitt Lymphoma who go on to receive SCT will be presented.

    Measured: Up to approximately 54 months

  19. Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT

    The percentage of participants with B-ALL who go on to receive SCT will be presented.

    Measured: Up to approximately 54 months

  20. Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T)

    The percentage of participants with B-ALL who go on to receive CAR-T will be presented.

    Measured: Up to approximately 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start16 Aug 2024
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395103
Sponsor's protocol ID
9999-01A
Other IDs
MK-9999-01A, LIGHTBEAM-U01, 2023-507178-41-00, U1111-1295-3459, jRCT2031250824, 2023
Status last verified
Oct 2026
First submitted
1 Feb 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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