Trials / Recruiting
RecruitingNCT06395103
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Months – 25 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- B-cell Acute Lymphoblastic Leukemia
- Diffuse Large B-cell Lymphoma
- Burkitt Lymphoma
- Neuroblastoma
- Ewing Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Zilovertamab vedotin | Administered via IV infusion |
Timeline
- Start date
- 2024-08-16
- Primary completion
- 2029-03-31
- Completion
- 2029-03-31
- First posted
- 2024-05-01
- Last updated
- 2026-04-13
Locations
67 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06395103. Inclusion in this directory is not an endorsement.