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

Last updated: June 18, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

BGB-11417

Sonrotoclax

Zanubrutinib

Clinical Study ID

NCT04277637
BGB-11417-101
2020-004641-37
CTR20231287
2024-515592-35-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 requiringtreatment

  2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors ofhematopoietic and lymphoid tissue) and defined as disease that relapsed after, orwas refractory to, at least 1 prior systemic therapy

  3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease thatrelapsed after, or was refractory to, at least two prior systemic therapies and haseither progressed following or is not a candidate for autologous stem celltransplant (due to comorbidities or non-responsiveness to salvage chemotherapy)

  4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 thathas transformed into a more aggressive lymphoma. Patients with transformation fromCLL 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 LymphocyticLeukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/Rdisease defined as disease that relapsed after, or was refractory to, at least 1prior 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 refractoryto, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of theinvestigator

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 2perpendicular 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 diameterOR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is consideredmeasurable 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

Key Exclusion Criteria:

  • Known current central nervous system involvement by lymphoma/leukemia

  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currentlysuspected 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.

Study Design

Total Participants: 437
Treatment Group(s): 5
Primary Treatment: BGB-11417
Phase: 1
Study Start date:
March 24, 2020
Estimated Completion Date:
May 31, 2027

Study Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales NSW 2139
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney (Kinghorn)

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Orange Health Service

    Orange, New South Wales 2800
    Australia

    Active - Recruiting

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales NSW 2800
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland QLD 4217
    Australia

    Site Not Available

  • John Flynn Private Hospital

    Tugun, Queensland QLD 4224
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia SA 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford PK, South Australia SA 5042
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria VIC 3128
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria VIC 3065
    Australia

    Site Not Available

  • St. Vincent Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria VIC 3000
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria VIC 3004
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia WA 6009
    Australia

    Site Not Available

  • Flinders Medical Centre

    Adelaide, 5042
    Australia

    Active - Recruiting

  • Monash Health Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • Peter McCallum Cancer Center (PMCC) Pharmacy

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • ASST Grande Ospedale Niguarda, Niguarda Piazza Maggiore 3, Blocco Sud Ponti Est Scala 10

    Milano, 20162
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Ospedale San Raffaele, Servizio Farmacia Piano -2, Via Olgettina 60 Settore B

    Milano, 20132
    Italy

    Active - Recruiting

  • Ospedale Santa Maria Della Misericordia

    Perugia, 6129
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale Di Ravenna

    Ravenna, 48121
    Italy

    Site Not Available

  • Ospedale S.Maria delle Croci, Dipart. Oncologia Ematologia, Farmacia Oncol. Via le Randi 5

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134
    Italy

    Site Not Available

  • Auckland City Hospital,

    Grafton, Auckland 1023
    New Zealand

    Active - Recruiting

  • Inpatient Pharmacy, LG Floor , North Shore Hospital

    Takapuna, Auckland 0620
    New Zealand

    Active - Recruiting

  • Wellington Regional Hospital

    Newtown, Wellington 0621
    New Zealand

    Active - Recruiting

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Site Not Available

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021
    New Zealand

    Site Not Available

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital St. Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Ico H Duran I Reynals

    Barcelona, 08907
    Spain

    Site Not Available

  • Institut Catalá Oncologia

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Vall D Hebron Institute of Oncology Vhio

    Barcelona, 08035
    Spain

    Site Not Available

  • START - Fund. Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Univ. de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital U. Marques Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Cancer and Haematology Centre

    Oxford, Headinton OX3 7LE
    United Kingdom

    Active - Recruiting

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • UCLA Hematologyoncology

    Los Angeles, California 90095-3075
    United States

    Site Not Available

  • Stanford Health Care

    Stanford, California 94305
    United States

    Active - Recruiting

  • North Western University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ann Arbor medical Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • University Of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Hackensack University

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The James Cancer Hospital and Solove Research Institute At Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Pittsburgh Health center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania 15232-1309
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030-3907
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.