- Part A: ≥ 12 months to < 21 years of age
- Part B: ≥ 22 years and ≤ 30 years of age at the time of study enrollment until part A is complete. Part B will expand to include patients ≥ 12 months and ≤ 30 years of age once Part A is complete.
- Recurrent or refractory solid tumors, excluding CNS tumors
- Must have either measurable or evaluable disease
- Prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible.
- Standard COG Phase 1 organ function requirements
- Excluded concomitant medications: Corticosteroids (unless on stable dosing), other investigational drugs, other anti-cancer agents, anti-GvHD agents post-transplant