Sign in

NCT06395103RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
90 (estimated)
First submitted
1 Feb 2024
Start date
16 Aug 2024
Primary completion date
31 Mar 2029
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06395103
EU CT number
2023-507178-41-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 90
  • From 16 Aug 2024 to the primary completion date, 31 Mar 2029
  • 72 sites in 23 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
  • 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.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Other illness

  • History of solid organ transplant.
  • Clinically significant (ie, active) cardiovascular disease.
  • Known history of liver cirrhosis.
  • Demyelinating form of Charcot-Marie-Tooth disease.
  • Diagnosed with Down syndrome.
  • History of human immunodeficiency virus (HIV) infection.
  • Contraindication or hypersensitivity to any of the study intervention components.
  • 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.

Other

  • Ongoing Grade \>1 peripheral neuropathy.

Who the study is looking for

  • 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.

Criteria the registry did not label

  • The main inclusion and exclusion criteria include but are not limited to the following:

Age in the registry: 6 months to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (72)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital-Oncology & Haematology ( Site 1996)
Coordinator of this site? Confirm its status
BrisbaneAustraliaRecruiting
Royal Children's Hospital-Children's Cancer Centre ( Site 1994)
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Sydney Children's Hospital ( Site 1997)
Coordinator of this site? Confirm its status
RandwickAustraliaRecruiting
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
Coordinator of this site? Confirm its status
BarretosBrazilRecruiting
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
Coordinator of this site? Confirm its status
CuritibaBrazilCompleted
Hospital de Clinicas de Porto Alegre ( Site 1265)
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilRecruiting
Alberta Children's Hospital ( Site 1227)
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
The Hospital for Sick Children ( Site 1225)
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)
Coordinator of this site? Confirm its status
ConcepciónChileRecruiting
Hospital Luis Calvo Mackenna ( Site 1879)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Hospital Carlos Van Buren ( Site 1880)
Coordinator of this site? Confirm its status
ValparaísoChileRecruiting
Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)
Coordinator of this site? Confirm its status
BarranquillaColombiaRecruiting
Hospital Pablo Tobon Uribe ( Site 1923)
Coordinator of this site? Confirm its status
MedellínColombiaRecruiting
IMAT S.A.S ( Site 1921)
Coordinator of this site? Confirm its status
MonteríaColombiaRecruiting
Fakultni Nemocnice Brno
Coordinator of this site? Confirm its status
Brno-SeverCzechiaRecruiting
Fakultni Nemocnice Motol a Homolka
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
Justus-Liebig-Universitaet Giessen
Coordinator of this site? Confirm its status
GiessenGermanyRecruiting
Universitaet Muenster
Coordinator of this site? Confirm its status
MuensterGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
Coordinator of this site? Confirm its status
TuebingenGermanyRecruiting
Rigshospitalet
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Sant Joan De Deu Barcelona Hospital
Coordinator of this site? Confirm its status
Esplugues De LlobregatSpainRecruiting
Hospital Infantil Universitario Nino Jesus
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting
Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)
Coordinator of this site? Confirm its status
BirminghamUnited KingdomRecruiting
University Hospital of Wales ( Site 1346)
Coordinator of this site? Confirm its status
CardiffUnited KingdomRecruiting
University College London Hospital ( Site 1350)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting
Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting
Nosokomeio Paidon I Agia Sofia
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Semmelweis University
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Sheba Medical Center ( Site 1675)
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital-Pediatrics ( Site 1972)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Prinses Maxima Centrum voor Kinderoncologie B.V.
Coordinator of this site? Confirm its status
UtrechtNetherlandsRecruiting
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Coordinator of this site? Confirm its status
GothenburgSwedenRecruiting
Narodny ustav detskych chorob
Coordinator of this site? Confirm its status
BratislavaSlovakiaRecruiting
National Taiwan University Hospital ( Site 1983)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Dana-Farber Cancer Institute ( Site 1013)
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
Coordinator of this site? Confirm its status
FargoUnited StatesRecruiting
Corewell Health ( Site 1001)
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
University of Texas MD Anderson Cancer Center ( Site 1007)
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
University of Iowa Health Care. ( Site 1017)
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
Children's Mercy Hospital ( Site 1024)
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Children's Hospital Los Angeles ( Site 1006)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey ( Site 1008)
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Yale New Haven Hospital ( Site 1012)
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center ( Site 1010)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Children's Hospital of Philadelphia (CHOP) ( Site 1021)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Oregon Health and Science University ( Site 1004)
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Intermountain - Primary Children's Hospital ( Site 1014)
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Johns Hopkins All Children's Hospital ( Site 1025)
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
New York Medical College ( Site 1023)
Coordinator of this site? Confirm its status
ValhallaUnited StatesRecruiting
Hacettepe Universite Hastaneleri ( Site 1961)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ankara Bilkent Şehir Hastanesi ( Site 1962)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ege Universitesi Hastanesi ( Site 1963)
Coordinator of this site? Confirm its status
BornovaTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.