A Phase 1/2 interventional study of sonrotoclax and Azacitidine in Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by BeOne Medicines · Phase 1/2, Interventional, and Treatment
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:
Researchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will:
Key Inclusion Criteria
Participants must meet all of the following criteria to be eligible for participation:
Have adequate hepatic function, defined as:
Acute Myeloid Leukemia (AML)-Specific Inclusion Criteria
B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)-Specific Inclusion Criteria
Key Exclusion Criteria
Participants will be excluded from participation if any of the following apply:
AML-Specific Exclusion Criteria
ALL-Specific Exclusion Criteria
Note: Other eligibility criteria may apply.
Participants with relapsed or refractory acute myeloid leukemia (R/R AML) will receive sonrotoclax in combination with azacitidine. Treatment will be administered in a dose-escalation phase (Part 1) to determine the recommended dose for expansion (RDFE), followed by a dose-expansion phase (Part 2) at the RDFE to further evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity.
Drug: sonrotoclax · Drug: Azacitidine
Participants with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-cell ALL) receive sonrotoclax in combination with inotuzumab ozogamicin and dexamethasone. Treatment will be administered in a dose-escalation phase (Part 1) to determine the recommended dose for expansion (RDFE), followed by a dose-expansion phase (Part 2) at the RDFE to further evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity. Enrollment may be paused based on futility criteria.
Drug: sonrotoclax · Drug: Inotuzumab ozogamicin · Drug: Dexamethasone
Administered orally as a tablet
Also known as: BGB-11417
administered intravenously or subcutaneously
administered via intravenous infusion
Also known as: Besponsa
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
No study locations are listed for this record.
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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