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

NCT07770698 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-18

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

sonrotoclax

Administered orally as a tablet

DRUG

Azacitidine

administered intravenously or subcutaneously

DRUG

Inotuzumab ozogamicin

administered via intravenous infusion

DRUG

Dexamethasone

administered via intravenous injection or orally

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-04-30
Completion
2031-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770698 on ClinicalTrials.gov