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

NCT07770698 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: BGB-11417-1092026-525319-15-00
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

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

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  From first dose through end of Cycle 1 (each cycle is 28 days); approximately 2 months

Secondary Outcomes (5)

• Complete Remission (CR) Rate

  Up to approximately 2 months

• Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) for Sonrotoclax

  Up to approximately 1 month

• Maximum Observed Plasma Concentration (Cmax) for Sonrotoclax

  Up to approximately 1 month

• Plasma Concentration Measured Immediately Prior to the Next Scheduled Dose (Ctrough) for Sonrotoclax

  Up to approximately 1 month

• Time to Maximum Observed Plasma Concentration (Tmax) for Sonrotoclax

  Up to approximately 1 month

Study Arms (2)

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.

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.

Drug: sonrotoclax; Drug: Inotuzumab ozogamicin; Drug: Dexamethasone

Interventions

sonrotoclax DRUG

Administered orally as a tablet

Also known as: BGB-11417

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

Azacitidine DRUG

administered intravenously or subcutaneously

Cohort 1: Sonrotoclax + Azacitidine (R/R AML)

Inotuzumab ozogamicin DRUG

administered via intravenous infusion

Also known as: Besponsa

Cohort 2: Sonrotoclax + Inotuzumab Ozogamicin + Dexamethasone (R/R B-cell ALL)

Dexamethasone DRUG

administered via intravenous injection or orally

Cohort 2: Sonrotoclax + Inotuzumab Ozogamicin + Dexamethasone (R/R B-cell ALL)

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Have minimum cardiac function as defined in the study protocol.
• 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.
• 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.

You may not qualify if:

• 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.
• Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
• Have AML with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), as determined by local assessment.
• 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.

Sponsors & Collaborators

• BeOne Medicines: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Burkitt Lymphoma; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Interventions

Azacitidine; Inotuzumab Ozogamicin; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: August 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: See plan description
• Access Criteria: See plan description