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RECRUITING Phase 1

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

NCT06395103 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL Zilovertamab vedotin

Study Locations (20)

New York

  • Memorial Sloan Kettering Cancer Center ( Site 1010) — New York
  • New York Medical College ( Site 1023) — Valhalla

California

  • Children's Hospital Los Angeles ( Site 1006) — Los Angeles

Colorado

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) — Aurora

Connecticut

  • Yale New Haven Hospital ( Site 1012) — New Haven

Florida

  • Johns Hopkins All Children's Hospital ( Site 1025) — St. Petersburg

Iowa

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 1017) — Iowa City

Massachusetts

  • Dana-Farber Cancer Institute ( Site 1013) — Boston

Michigan

  • Corewell Health ( Site 1001) — Grand Rapids

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-08-16
Est. Completion 2029-03-31
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06395103

The ClinicalTrials.gov registry entry for NCT06395103 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention — of which Zilovertamab vedotin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06395103 reports 20 study locations spanning 19 distinct geographic areas — top geographies include New York, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06395103 about?

NCT06395103 is a clinical study titled "Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)". 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...

What is the current status of trial NCT06395103?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2024-08-16. Estimated completion is 2029-03-31.

What conditions does trial NCT06395103 study?

This clinical trial studies the following conditions: Neuroblastoma, Ewing Sarcoma, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, B-cell Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06395103?

The interventions under investigation include: Zilovertamab vedotin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06395103?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06395103 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial