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
- Diseases
- Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma, Neuroblastoma, Childhood cancers, Sarcoma
- 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
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queensland Children's Hospital-Oncology & Haematology ( Site 1996) Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Royal Children's Hospital-Children's Cancer Centre ( Site 1994) Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Sydney Children's Hospital ( Site 1997) Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264) Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268) Coordinator of this site? Confirm its status | Curitiba | Brazil | Completed |
| Hospital de Clinicas de Porto Alegre ( Site 1265) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| 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 Preto | Brazil | Recruiting |
| Alberta Children's Hospital ( Site 1227) Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| McGill University Health Centre-Pediatric HematologyOncology ( Site 1223) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Hospital for Sick Children ( Site 1225) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881) Coordinator of this site? Confirm its status | Concepción | Chile | Recruiting |
| Hospital Luis Calvo Mackenna ( Site 1879) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Hospital Carlos Van Buren ( Site 1880) Coordinator of this site? Confirm its status | Valparaíso | Chile | Recruiting |
| Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| Hospital Pablo Tobon Uribe ( Site 1923) Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| IMAT S.A.S ( Site 1921) Coordinator of this site? Confirm its status | Montería | Colombia | Recruiting |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Birmingham Children's Hospital-Oncology/Haematology ( Site 1349) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| University Hospital of Wales ( Site 1346) Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| University College London Hospital ( Site 1350) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348) Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347) Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Nosokomeio Paidon I Agia Sofia Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674) Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Sheba Medical Center ( Site 1675) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital-Pediatrics ( Site 1972) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Narodny ustav detskych chorob Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| National Taiwan University Hospital ( Site 1983) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Dana-Farber Cancer Institute ( Site 1013) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003) Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Corewell Health ( Site 1001) Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 1007) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa Health Care. ( Site 1017) Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Children's Mercy Hospital ( Site 1024) Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Children's Hospital Los Angeles ( Site 1006) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 1008) Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Yale New Haven Hospital ( Site 1012) Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 1010) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia (CHOP) ( Site 1021) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health and Science University ( Site 1004) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Intermountain - Primary Children's Hospital ( Site 1014) Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015) Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Johns Hopkins All Children's Hospital ( Site 1025) Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| New York Medical College ( Site 1023) Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
| Hacettepe Universite Hastaneleri ( Site 1961) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent Şehir Hastanesi ( Site 1962) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ege Universitesi Hastanesi ( Site 1963) Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.