Relapsed Acute Myeloid LeukemiaPhase 1/2NCT07770698
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing sonrotoclax, Azacitidine and Inotuzumab ozogamicin in people with Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by BeOne Medicines.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- sonrotoclax, Azacitidine and Inotuzumab ozogamicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2031
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
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?
Read more
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.
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Relapsed, Pediatric ALL
- Being tested
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin, Dexamethasone
- Keywords
- R/R B-cell ALL, R/R AML, Pediatric AML, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Pediatric ALL, B Cell, Pediatric ALL, Pediatric ALL, Relapsed, Pediatric Cancer, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Sonrotoclax, Pediatric
- Medical subject headings
- Leukemia, Myeloid, Acute, Burkitt Lymphoma, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonrotoclaxDrug
Also called BGB-11417
Administered orally as a tablet
AzacitidineDrug
administered intravenously or subcutaneously
Inotuzumab ozogamicinDrug
Also called Besponsa
administered via intravenous infusion
DexamethasoneDrug
administered via intravenous injection or orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Sonrotoclax + Azacitidine (R/R AML) | Experimental | 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. Receives: Drug: sonrotoclax; Drug: Azacitidine |
| Cohort 2: Sonrotoclax + Inotuzumab Ozogamicin + Dexamethasone (R/R B-cell ALL) | Experimental | 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. Receives: Drug: sonrotoclax; Drug: Inotuzumab ozogamicin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: From first dose through end of Cycle 1 (each cycle is 28 days); approximately 2 months
Secondary outcomes (5)
Complete Remission (CR) Rate
Percentage of participants achieving a best overall response of complete remission (CR), as assessed by investigator's review
Measured: Up to approximately 2 months
Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) for Sonrotoclax
Measured: Up to approximately 1 month
Maximum Observed Plasma Concentration (Cmax) for Sonrotoclax
Measured: Up to approximately 1 month
Plasma Concentration Measured Immediately Prior to the Next Scheduled Dose (Ctrough) for Sonrotoclax
Measured: Up to approximately 1 month
Time to Maximum Observed Plasma Concentration (Tmax) for Sonrotoclax
Measured: Up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startOct 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770698
- Sponsor's protocol ID
- BGB-11417-109
- Other IDs
- 2026-525319-15-00
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.