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

Sponsor
BeOne Medicines
Study ID
NCT07770698
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • B-cell Acute Lymphoblastic Leukemia
  • Pediatric ALL
  • Pediatric ALL, B Cell
  • Pediatric ALL, Relapsed
  • Pediatric AML
  • Pediatric Cancer
  • R/R AML
  • R/R B-cell ALL
  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • sonrotoclax — DRUG
    Administered orally as a tablet
  • Azacitidine — DRUG
    administered intravenously or subcutaneously
  • Inotuzumab ozogamicin — DRUG
    administered via intravenous infusion
  • Dexamethasone — DRUG
    administered via intravenous injection or orally

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2030
Completion
Sep 30, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Sonrotoclax + Azacitidine (R/R AML)
    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.
  • Experimental: Cohort 2: Sonrotoclax + Inotuzumab Ozogamicin + Dexamethasone (R/R B-cell ALL)
    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.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ 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. ]

Central Contacts

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