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.
None
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.
History of solid organ transplant.
Clinically significant (ie, active) cardiovascular disease.
Single group
Zilovertamab vedotin
Biological/VaccineAdministered via IV infusion
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
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.
Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who experience at least 1 AE will be presented.
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who receive a dose modification due to an AE will be presented.
Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody
Blood samples collected at designated time points will be used to determine the AUC of total antibody.
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody
Blood samples collected at designated time points will be used to determine the Cmax of total antibody.
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody
Blood samples collected at designated time points will be used to determine the Ctrough of total antibody.
Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody
Blood samples collected at designated time points will be used to determine the t1/2 of total antibody.
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