Key Inclusion Criteria!
- Age: 6 months to ≤ 21 years old at the time of study enrollment
- Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis. Phase II: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma. Patients with solid tumors must have measurable or evaluable (for neuroblastoma and Ewing sarcoma) disease.
- Adequate bone marrow, renal and liver function.
Key Exclusion Criteria:
- Active or uncontrolled infection ).
- 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 (per institutional guidelines).
- Patients with central nervous system (CNS) malignancies.