Home › Trials › NCT06395103

Zilovertamab Vedotin for Pediatric and Young Adult Cancer Patients

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

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06395103

This study is testing a new drug called zilovertamab vedotin to see if it can help kids and young adults with certain types of cancer that haven't responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment90 (estimated)
Ages6 Months to 25 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone, zilovertamab
Locations67 sites (Los Angeles, California and 66 other locations)
Trial IDNCT06395103 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of zilovertamab vedotin in pediatric and young adult participants with relapsed or refractory hematologic malignancies, such as B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma, as well as solid tumors like neuroblastoma and Ewing sarcoma. It is part of a larger platform study aimed at understanding the potential of this treatment in various cancer types. Participants will receive the investigational drug and be monitored for responses and side effects.

Who should consider this trial

Good fit: Ideal candidates include pediatric and young adult patients diagnosed with specific hematologic malignancies or solid tumors as outlined in the eligibility criteria.

Not a fit: Patients with a history of solid organ transplant, significant cardiovascular disease, or certain other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for young patients with difficult-to-treat cancers.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific application of zilovertamab vedotin in this population is novel.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Los Angeles, California and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell Acute Lymphoblastic LeukemiaDiffuse Large B-cell LymphomaBurkitt LymphomaNeuroblastomaEwing Sarcoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.