A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

NCT06697184 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: BGB-11417-108
• Study Type: interventional
• Target: 56
• Locations: 4 countries
• Sites: 17

Brief Summary

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Conditions

CLL; Chronic Lymphocytic Leukemia

Keywords

CLL previously untreated; Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants who Experience Tumor Lysis Syndrome (TLS)

  TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window

  Approximately 4 months

Secondary Outcomes (2)

• Number of Participants with Adverse Events (AEs)

  Approximately 4 months

• Number of Participants with Dose Modifications During the SLT Evaluation Window

  Approximately 4 months

Study Arms (2)

Part 1: Schedule Calibration

EXPERIMENTAL

Participants will receive zanubrutinib monotherapy with fixed duration, followed by combination sonrotoclax with zanubrutinib at protocol-defined ramp-up schedules until target daily dose will be reached.

Drug: Sonrotoclax; Drug: Zanubrutinib

Part 2: Schedule Expansion

EXPERIMENTAL

Participants will receive zanubrutinib monotherapy with fixed duration, followed by combination sonrotoclax with zanubrutinib at ramp-up schedules as determined in Part 1.

Drug: Sonrotoclax; Drug: Zanubrutinib

Interventions

Sonrotoclax DRUG

Administered orally

Also known as: BGB-11417

Part 1: Schedule Calibration; Part 2: Schedule Expansion

Zanubrutinib DRUG

Administered orally

Also known as: BGB-3111

Part 1: Schedule Calibration; Part 2: Schedule Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable ECOG Performance Status ≤ 2.
• Adequate organ function and no very recent transfusion or blood growth factor
• Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
• Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
• At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.

You may not qualify if:

• Participants unable to comply with the requirements of the protocol
• Serologic status reflecting active viral HBV or HCV infection
• Positive HIV serology (HIVAb) status unless certain conditions are met.
• Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
• Prior systemic treatment for the CLL
• Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment

Sponsors & Collaborators

• BeiGene: lead

Study Sites (17)

Moffitt Cancer Center

Tampa, Florida, 33612-9496, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205-2003, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5418, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433, United States

Location

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

Location

Genesiscare St Andrews

Adelaide, South Australia, SA 5000, Australia

Location

Cabrini Hospital Malvern

Malvern East, Victoria, VIC 3144, Australia

Location

The Alfred Hospital

Melbourne, Victoria, VIC 3004, Australia

Location

Rockingham Hospital

Cooloongup, Western Australia, WA 6168, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

Location

Chu Dijon

Dijon, 21000, France

Location

Chu Montpellier Hopital Saint Eloi

Montpellier, 34090, France

Location

Iuct Oncopole

Toulouse, 31100, France

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

St Jamess University Hospital

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

GB (2); US (6); FR (3); AU (6)