🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04277637
Active, not recruiting Phase 1

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

NCT04277637 · tracked via the Priya Life Science UK tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2020-03-24
Last updated
2026-06-22

Condition(s) studied

Mature B-Cell Malignancies

Investigational drug(s) / intervention(s)

SonrotoclaxZanubrutinibObinutuzumab

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.

Study summary

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Confirmed diagnosis of one of the following: 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 Key Exclusion Criteria: * Known current central nervous system involvement by lymphoma/leukemia * 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
UCLA Hematologyoncology Los Angeles California
Northwestern University Chicago Illinois
University of Kansas Medical Center Research Institute Kansas City Kansas
Massachusetts General Hospital Boston Massachusetts
Mayo Clinic Rochester Rochester Minnesota
University of Nebraska Medical Center Omaha Nebraska
John Theurer Cancer Center Hackensack University Medical Center Hackensack New Jersey
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center Mskcc New York New York
The James Cancer Hospital and Solove Research Institute At Ohio State University Columbus Ohio
Upmc Hillman Cancer Center(Univ of Pittsburgh) Pittsburgh Pennsylvania
Md Anderson Cancer Center Houston Texas
Fred Hutchinson Cancer Research Center Seattle Washington
Concord Repatriation General Hospital Concord New South Wales
Orange Health Service (Central West Cancer Care Centre) Orange New South Wales
Pindara Private Hospital Benowa Queensland
John Flynn Private Hospital Tugun Queensland
Royal Adelaide Hospital Adelaide South Australia
Flinders Medical Centre Bedford PK South Australia
Box Hill Hospital Box Hill Victoria
Monash Health Clayton Victoria
St Vincents Hospital Melbourne Fitzroy Victoria
Peter Maccallum Cancer Centre Melbourne Victoria
The Alfred Hospital Melbourne Victoria
Linear Clinical Research Nedlands Western 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
North Shore Hospital Auckland New Zealand
Auckland City Hospital Auckland New Zealand
Wellington Regional Hospital (Ccdhb) Wellington New Zealand
Vall D Hebron Institute of Oncology Vhio Barcelona Spain
Hospital Clinic de Barcelona Barcelona Spain
Hospital de La Santa Creu I Sant Pau Barcelona Spain
Ico H Duran I Reynals Barcelona Spain
Start Madrid Fundacion Jimenez Diaz Madrid Spain

+ 3 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile →

More BeOne Medicines trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04277637 on ClinicalTrials.gov ↗ ← All trials in the UK