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

Last updated: February 14, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

obinutuzumab

BGB-11417

Sonrotoclax

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: obinutuzumab
Phase: 1
Study Start date:
March 24, 2020
Estimated Completion Date:
August 30, 2027

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney (Kinghorn)

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Saint Vincents Hospital Sydney

    Darlinghust, New South Wales 2010
    Australia

    Site Not Available

  • Orange Health Service

    Orange, New South Wales 2800
    Australia

    Active - Recruiting

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales 2800
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • John Flynn Private Hospital

    Tugun, Queensland 4224
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford PK, South Australia 5042
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • St. Vincent Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 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

  • Uniklinik Koln (Aor)

    Koln, 50937
    Germany

    Site Not Available

  • Klinik Fur Hamatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie Und Tropenmedizin Mu

    Munich, 80804
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081
    Germany

    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

    Milano, 20132
    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, 6132
    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

    Site Not Available

  • Inpatient Pharmacy, LG Floor , North Shore Hospital

    Takapuna, Auckland 0620
    New Zealand

    Active - Recruiting

  • Wellington Regional Hospital

    Newtown, Wellington 0621
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • North Shore Hospital

    Takapuna, 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, 8036
    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, 08025
    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

  • Clinica Universidad de Navarra Pamplona

    Pamplona, 31008
    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

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    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

  • University Hospitals of Leicester Nhs Trust Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB
    United Kingdom

    Site Not Available

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford, OX42PG
    United Kingdom

    Site Not Available

  • UCLA Hematologyoncology

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Stanford Health Care

    Stanford, California 94305
    United States

    Site Not Available

  • 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
    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

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    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
    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
    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
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

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