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Looking for participantsPhase1/Phase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06395103

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zilovertamab vedotin (biological)
How long the study runs
Study runs about 55 months (dates as stated)
About the drug or intervention
Zilovertamab vedotin — biological: Administered via IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Months to 25 Years
Who
All
Number of participants
90
Started
2024-08-16
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for b-cell acute lymphoblastic leukemia
  • • Phase1/Phase2 - 90 participants
  • • Substudy 01A is part of a platform study

Who can take part?

  • • Ages 6 Months to 25 Years
  • • Diagnosed with b-cell acute lymphoblastic leukemia

Where?

  • • Birmingham - Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)
  • • Newcastle upon Tyne - Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
  • • London - University College London Hospital ( Site 1350)
  • • Sutton - Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

B-cell Acute Lymphoblastic LeukemiaDiffuse Large B-cell LymphomaBurkitt LymphomaNeuroblastomaEwing Sarcoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Months - 25 Years
  • Who can join: All genders

What the study is looking for

  • ✓For blood malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to...
  • ✓For solid tumor malignancies: confirmed by a biopsy diagnosis of neuroblastoma or Ewing sarcoma.

Who cannot take part

  • ✗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.
See the full criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Criteria: * 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. * 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.

Where Is This Study? (5 UK sites)

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

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441213338233

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

Newcastle upon Tyne NE1 4PL, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0191 282 1014

University College London Hospital ( Site 1350)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02034472485

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

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 8642 6011

University Hospital of Wales ( Site 1346)

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402921842107

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10