Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults
Conditions
Brief summary
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT), Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs, Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL), Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma
Detailed description
Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody, Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody, Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Cmax of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Ctrough of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: t1/2 of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Cmax of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Ctrough of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: t1/2 of Monomethyl Auristatin E (MMAE), Part 2: Number of Participants Who Experience One or More Adverse Events (AEs), Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs, Part 2: Number of Participants Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Incidence of Antidrug antibodies (ADAs) to Zilovertamab Vedotin, Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT), Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT, Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT), Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs, Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL), Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody, Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody, Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Cmax of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Ctrough of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: t1/2 of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Cmax of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Ctrough of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: t1/2 of Monomethyl Auristatin E (MMAE), Part 2: Number of Participants Who Experience One or More Adverse Events (AEs), Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs, Part 2: Number of Participants Who Receive Dose Modification Due to AEs, Part 1 and P | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Slovakia, Spain, Sweden