The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)
Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)
Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)
Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)
Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)
Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)
Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Overall Response Rate (ORR) (Phase 1 and 2)
Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)