A Phase 12 Study of Zilovertamab Vedotin Given by IV Infusion to Children and Young Adults With Blood Cancers or Solid Tumors

What this Trial Is About

Researchers are studying the safety and effectiveness of zilovertamab vedotin in children and young adults aged 6 to 25 years with certain blood cancers and solid tumors, including relapsed or refractory B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphomaBurkitt lymphoma, neuroblastoma, and Ewing sarcoma. This phase 12 study aims to assess how well this treatment works and to monitor any side effects in these young participants. Participants receive escalating doses of zilovertamab vedotin through an intravenous infusion once every 21 days in repeated cycles. The study includes both dose-finding and efficacy evaluation stages to determine the best dose and treatment impact over time. Treatment continues with cycles every three weeks, with ongoing monitoring throughout the study period. During the trial, participants will have regular assessments including monitoring for adverse events, dose modifications, and treatment discontinuations. Blood samples will be collected to study how the drug moves through the body and its effects. The main outcomes measured include the number of participants experiencing dose-limiting toxicities, response rates for different cancers, and duration of response. This study may last up to approximately 54 months to fully evaluate safety and effectiveness.

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