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RecruitingLast updated: 11 June 2026

LIGHTBEAM-U01 Substudy 01A: Testing the antibody-drug conjugate Zilovertamab Vedotin in children and young adults with some blood cancers and some solid cancersA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People0 - 25

Trial acronym

LIGHTBEAM-U01 Substudy 01A

Clinical summary

Summary

This study, Substudy 01A, is part of a platform study.

The purpose of this study is to assess how safe and effective treatment with zilovertamab vedotin is in paediatric participants with relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma, and in paediatric and young adult participants with Ewing sarcoma.

Zilovertamab vedotin will be given in escalating doses via intravenous (IV) infusion every 3 weeks.

Conditions

This trial is treating people with B-cell acute lymphoblastic leukaemia, diffuse large B-cell lymphoma, Burkitt lymphoma, neuroblastoma or Ewing sarcoma

Eligibility

Inclusion

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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06395103 *
  • 2023-507178-41-00 *
  • 9999-01A; MK-9999-01A; LIGHTBEAM-U01; U1111-1295-3459

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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

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