Key Inclusion Criteria:
- Age: 6 months – 21 years
- Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis
- Adequate bonemarrow, reanal and lver function
- Key Exclusion Criteria:
- Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
- Diabetes mellitus.
- Uncontrolled arterial hypertension despite optimal medical management
- Patients with central nervous system (CNS) malignancies.