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Substudy 01A: Zilovertamab Vedotin for Pediatric and Young Adult Cancers

This study, called Substudy 01A, is testing a new treatment called zilovertamab vedotin for children and young adults with certain blood cancers (B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma) or solid tumors (Neuroblastoma, Ewing Sarcoma). The main goal is to see how safe zilovertamab vedotin is and if it causes any serious side effects. Researchers will also look at how well the treatment works. You might be able to join if you are between 6 months and 25 years old and have one of these specific cancers that has come back or not responded to previous treatments. The study aims to enroll 90 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is part of a larger platform study, and the planned enrollment is 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 54 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06395103

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

Recruiting
PHASE1Ages 6–25InterventionalTreatment
Merck Sharp & Dohme LLC
~90 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Zilovertamab vedotin

At a glance

Recruiting sites
66 of 67 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
Measured over Up to 42 days
+5 more outcomes measured

Conditions

B-cell Acute Lymphoblastic Leukemia
Diffuse Large B-cell Lymphoma
Burkitt Lymphoma
Neuroblastoma
Ewing Sarcoma

Explore related trials

B Acute Lymphoblastic LeukemiaBurkitt LymphomaDiffuse Large B-Cell LymphomaEwing SarcomaHematologic NeoplasmNeuroblastomaSolid Neoplasm

Where it's being run

67 sites across 60 states
New York2
São Paulo2
North Rhine-Westphalia2
Israel2
South Korea2
Turkey (Türkiye)2
England2
California1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

What this trial measures

  • Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)Up to 42 days

    Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose.

  • Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)Up to approximately 54 months

    An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who experience at least 1 AE will be presented.

  • Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEsUp to approximately 54 months

    An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.

  • Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEsUp to approximately 54 months

    An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who receive a dose modification due to an AE will be presented.

  • Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)Up to approximately 54 months

    OR for participants with B-ALL is defined as complete response (CR) or complete response with incomplete hematologic recovery (CRi) based on investigator's assessment per Ponte-di-Legno Consortium criteria. For Part 1 and Part 2, the OR for participants with B-ALL as assessed by investigator will be presented.

  • Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing SarcomaUp to approximately 54 months

    OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma is defined as complete response (CR) or partial response (PR) based on investigator's assessment per International Pediatric Non-Hodgkin Lymphoma (IPNHL) Response Criteria for participants with DLBCL/Burkitt lymphoma, per International Neuroblastoma Response Criteria (INRC) for neuroblastoma, and per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Ewing sarcoma. For Part 1 and Part 2, the OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma as assessed by investigator will be presented.