Tests zilovertamab vedotin in young patients with blood cancers or solid tumors
Tests zilovertamab vedotin in children with leukemia, lymphoma, neuroblastoma or Ewing sarcoma.
Plain-language title generated from the registry record
Registry title: Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
Key facts
- Where
- Bratislava, SlovakiaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphoma or Burkitt lymphoma, neuroblastoma, or Ewing sarcoma.
- Age
- From 6 Months to 25 Years.
- Sex
- All sexes can join.
- Disease stage
- Confirmed B-precursor B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma/Burkitt lymphoma. Or confirmed neuroblastoma or Ewing sarcoma. The summary mentions relapsed or refractory disease.
- Earlier treatment
- No systemic anticancer therapy or investigational agent within 4 weeks before the first dose. No radiotherapy within 4 weeks before the start. No live or live-attenuated vaccine within 30 days.
Main reasons for not taking part
- History of solid organ transplant
- Diagnosed with Down syndrome
- History of HIV infection
- Known history of liver cirrhosis or Hepatitis B, or active Hepatitis C
- Active infection needing systemic therapy
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Does the patient have an infection that is not under control, or HIV or hepatitis B or C?
- Has the patient had Down syndrome (an extra copy of chromosome 21) diagnosed?
Source: NCT06395103, who can take part
Where in Slovakia
- Narodny ustav detskych chorobBratislava, SlovakiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06395103EU 2023-507178-41-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Ongoing Grade >1 peripheral neuropathy.
The main inclusion and exclusion criteria include but are not limited to the following:.