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Taking people in South KoreaPhase 1/2

Tests zilovertamab vedotin in young patients with blood cancers or solid tumors

Tests zilovertamab vedotin in children with leukemia, lymphoma, neuroblastoma or Ewing sarcoma.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Seoul, South KoreaSee the 2 sitesAlso in 22 other countries, 70 sites
Trial code
Registry title
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
Status
Recruiting
Phase
Phase 1/2
People taking part
90 people, planned
Started
16 Aug 2024
Expected to end
31 Mar 2029
Type of study
Interventional
Treatments tested
  • Zilovertamab vedotin
Record updated
30 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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 take part

  • 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

Other criteria

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

Check if you might fit

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?

Where in South Korea

Also in 22 other countries, 70 sites

  • Asan Medical Center-Pediatrics - Pedicatric Oncology (Site 1973)Seoul, South KoreaContact: Study CoordinatorTaking people
  • Seoul National University Hospital-Pediatrics (Site 1972)Seoul, South KoreaContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Zilovertamab vedotinTreatment being tested

    Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests zilovertamab vedotin in young patients with blood cancers or solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06395103, who can take part
Record updated
30 October 2026