A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.
2 other identifiers
interventional
258
4 countries
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2025
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2032
June 8, 2026
June 1, 2026
4.9 years
November 18, 2024
June 5, 2026
Conditions
Keywords
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
Up to approximately 4 months
Secondary Outcomes (2)
Number of Participants with Adverse Events (AEs)
Up to approximately 4 months
Number of Participants with Dose Modifications During the SLT Evaluation Window
Up to approximately 4 months
Study Arms (2)
Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL
EXPERIMENTALParticipants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up)
Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCL
EXPERIMENTALParticipants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria.
Interventions
Administered orally
Administered orally
Eligibility Criteria
You may qualify if:
- Stable Eastern Cooperative Oncology Group (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 ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.
- Only for participants with Chronic Lymphocytic Leukemia (CLL):
- 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.
- Only for participants with Mantle cell lymphoma (MCL):
- Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).
- Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.
- Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter.
You may not qualify if:
- Participants unable to comply with the requirements of the protocol
- Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (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
- Prior exposure to a BCL-2 inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (17)
Moffitt Cancer Center
Tampa, Florida, 33612-9496, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Genesiscare St Andrews
Adelaide, South Australia, SA 5000, Australia
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Rockingham Hospital
Cooloongup, Western Australia, WA 6168, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Chu Dijon
Dijon, 21000, France
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Iuct Oncopole
Toulouse, 31100, France
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
St Jamess University Hospital
Leeds, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Director
CONTACT
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)
November 30, 2029
Study Completion (Estimated)
November 30, 2032
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.