A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia

Key Inclusion Criteria

Participants must meet all of the following criteria to be eligible for participation:

• Have a performance status of Lansky ≥50 for participants ≤16 years of age or Karnofsky ≥50 for participants >16 years of age.
• Have adequate renal function, defined as an estimated or measured glomerular filtration rate (GFR) ≥60 mL/min.
• Have adequate hepatic function, defined as:

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × the institutional upper limit of normal (ULN)
• Total bilirubin ≤1.5 × the institutional ULN.
• Have minimum cardiac function as defined in the study protocol.

Acute Myeloid Leukemia (AML)-Specific Inclusion Criteria

• Have a histologically confirmed diagnosis of acute myeloid leukemia (AML) that is relapsed or refractory (R/R) after ≥2 prior lines of systemic therapy.
• Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology. Participants with extramedullary, non-central nervous system (CNS) disease are eligible.

B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)-Specific Inclusion Criteria

• Have a histologically confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is R/R after ≥2 prior lines of systemic therapy, including at least 1 line of blinatumomab-based therapy.
• Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology.
• Have leukemic blasts expressing cluster of differentiation 22 (CD22) on the cell surface, as assessed by flow cytometry of a bone marrow aspirate.

Key Exclusion Criteria

Participants will be excluded from participation if any of the following apply:

• Have central nervous system (CNS) 2 or CNS 3 disease at screening.
• Have toxicity from prior anticancer therapy that has not recovered to ≤Grade 1, as defined by the applicable toxicity grading criteria.
• Have a history of prior allogeneic stem cell transplantation <90 days from enrollment or if if ≥ 90 days from enrollment, with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.

AML-Specific Exclusion Criteria

• Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
• Have AML with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), as determined by local assessment.

ALL-Specific Exclusion Criteria

• Have Philadelphia chromosome-positive (Ph+) ALL with a breakpoint cluster region::Abelson murine leukemia viral oncogene homolog 1 (BCR::ABL1) fusion.
• Have received prior therapy with a B-cell lymphoma 2 (BCL-2) inhibitor.

Note: Other eligibility criteria may apply.