The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are: * Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines? * How does the body absorb, process, and remove sonrotoclax? * Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia? Researchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will: * Take sonrotoclax in combination with other anti-cancer medicines * Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments. * Provide blood samples to measure how the body processes sonrotoclax. * Have tests to evaluate how their leukemia responds to treatment. * Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered orally as a tablet
administered intravenously or subcutaneously
administered via intravenous infusion
administered via intravenous injection or orally
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities,. Includes adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: From first dose of study drug to 30 days after last dose; up to approximately 12 months in cohort 1 and 4 months in cohort 2.
Part 1: Recommended Dose for Expansion (RDFE) of Sonrotoclax
Dose selected based on safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity observed in Part 1, as determined by the Safety Monitoring Committee (SMC)
Time frame: From first dose through end of Cycle 1 (each cycle is 28 days); approximately 2 months
Complete Remission (CR) Rate
Percentage of participants achieving a best overall response of complete remission (CR), as assessed by investigator's review
Time frame: Up to approximately 2 months
Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) for Sonrotoclax
Time frame: Up to approximately 1 month
Maximum Observed Plasma Concentration (Cmax) for Sonrotoclax
Time frame: Up to approximately 1 month
Plasma Concentration Measured Immediately Prior to the Next Scheduled Dose (Ctrough) for Sonrotoclax
Time frame: Up to approximately 1 month
Time to Maximum Observed Plasma Concentration (Tmax) for Sonrotoclax
Time frame: Up to approximately 1 month
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