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NCT06395103 · ClinicalTrials.gov registry record · Phase 1
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
A Phase 1 study of Diffuse Large B Cell Lymphoma and Neuroblastoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06395103: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and Neuroblastoma, sponsored by Merck Sharp & Dohme.
NCT06395103 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Neuroblastoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 90 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06395103, a Phase 1 study of Diffuse Large B Cell Lymphoma and Neuroblastoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-08-16 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 1 |
What NCT06395103 shows while recruiting
NCT06395103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (59% lower).
The record links to 5 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Zilovertamab vedotin is the first listed.
NCT06395103 names 20 study sites across 19 states, led by New York, California, Colorado.
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: Diffuse Large B Cell Lymphoma, Neuroblastoma, Ewing Sarcoma, Burkitt Lymphoma, B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06395103?
The interventions under investigation include: Zilovertamab vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT06395103?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06395103's enrollment target sits among peer trials
90 45th of 114 higher than 70 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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