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

Trial details

Who runs it

Merck Sharp & Dohme LLC

Trial code

NCT06395103EU 2023-507178-41-00

Record updated

2026. október 30.

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis; 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; Participants who have not adequately recovered from major surgery or have ongoing surgical complications; History of solid organ transplant; Clinically significant (ie, active) cardiovascular disease; Known history of liver cirrhosis; Demyelinating form of Charcot-Marie-Tooth disease; Diagnosed with Down syndrome; History of human immunodeficiency virus (HIV) infection; Contraindication or hypersensitivity to any of the study intervention components; 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; Ongoing Grade >1 peripheral neuropathy.

The main inclusion and exclusion criteria include but are not limited to the following:.

ClinicalTrials.gov NCT06395103 · EU CTIS 2023-507178-41-00