Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
NCT ID: NCT04277637
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
437 participants
INTERVENTIONAL
2020-03-24
2027-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sonrotoclax Monotherapy Dose Finding: Part 1
Participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL) or transformed NHL, mantle cell lymphoma (MCL); Waldenströms macroglobulinemia (WM); and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive oral sonrotoclax evaluated as monotherapy.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Sonrotoclax Monotherapy Expansion Cohorts: Part 2
Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral sonrotoclax at the RP2D dose to further define the safety profile.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Sonrotoclax + Zanubrutinib Combination Therapy Dose Finding: Part 3
Participants with R/R MCL, R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 4
Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; R/R MCL; R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib at an RP2D dose to further define the safety profile.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Sonrotoclax + Zanubrutinib Combination Therapy Dose Escalation: Part 5
Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Obinutuzumab
Given as an intravenous infusion administered per label.
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 6
Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib at an RP2D dose to further define the safety profile.
Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Obinutuzumab
Given as an intravenous infusion administered per label.
Interventions
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Sonrotoclax
Film-coated tablets administered once daily at a dose as specified in the treatment arm
Zanubrutinib
320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
Obinutuzumab
Given as an intravenous infusion administered per label.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
NHL Cohorts:
1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
CLL/SLL Cohorts:
5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
MCL cohorts:
6. WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
WM cohorts:
g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)
* Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
1. CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
2. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
3. WM: serum immunoglobulin (Ig) M level \> 0.5 g/dL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate organ function
* Adequate pancreatic function indicated by:
1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)
2. Serum lipase ≤ 1.5 x ULN
Exclusion Criteria
* Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
* Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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UCLA Hematologyoncology
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, , Germany
Ospedale San Raffaele
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Ospedale Santa Maria Della Misericordia
Perugia, , Italy
Azienda Unita Sanitaria Locale Di Ravenna
Ravenna, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Centroricerche Cliniche Di Verona Srl
Verona, , Italy
Auckland City Hospital
Auckland, , New Zealand
North Shore Hospital
Takapuna, , New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, , New Zealand
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Vall D Hebron Institute of Oncology Vhio
Barcelona, , Spain
Ico H Duran I Reynals
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Clinica Universidad de Navarra Pamplona
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
The Leeds Teaching Hospitals Nhs Trust
Leeds, , United Kingdom
Countries
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Other Identifiers
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2024-515592-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
2020-004641-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BGB-11417-101
Identifier Type: -
Identifier Source: org_study_id
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