Clinical trial • Phase I/II • Oncology
BGB-16673 for Relapsed or Refractory B-cell malignancies | Diffuse large B-cell lymphoma | Follicular lymphoma | Chronic lymphocytic leukemia | Mantle cell lymphoma | Marginal zone lymphoma | Waldenström macroglobulinaemia | Richter's syndrome
Phase I/II trial of BGB-16673 for Relapsed or Refractory B-cell malignancies | Diffuse large B-cell lymphoma | Follicular lymphoma | Chronic lymphocytic l…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or Refractory B-cell malignancies | Diffuse large B-cell lymphoma | Follicular lymphoma | Chronic lymphocytic leukemia | Mantle cell lymphoma | Marginal zone lymphoma | Waldenström macroglobulinaemia | Richter's syndrome
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody|Bispecific antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-05-2025
- First CTIS Authorization Date
- 23-09-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 15 sites in Germany, Italy, Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation elements are included to identify recommended dose(s) for expansion (RDFE[s]) and assess dose-limiting toxicities (Part 1a); master protocol with substudy-specific escalation/expansion elements
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 271
Eligibility
Recruits 271 Vulnerable population selected. All participants must be capable of giving written informed consent and must sign an informed consent form (ICF). Study-specific and substudy-specific subject information sheets and ICFs are provided; ICF documentation includes versions in German, Italian and Polish. Paediatric subjects are excluded, so assent is not applicable..
- Pregnancy Exclusion
- Female 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 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
- Vulnerable Population
- Vulnerable population selected. All participants must be capable of giving written informed consent and must sign an informed consent form (ICF). Study-specific and substudy-specific subject information sheets and ICFs are provided; ICF documentation includes versions in German, Italian and Polish. Paediatric subjects are excluded, so assent is not applicable.
Inclusion criteria
- {"criterion_text":"- Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF"}
- {"criterion_text":"- Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Sub-study 2)"}
- {"criterion_text":"- Confirmed diagnosis of a R/R B-cell malignancy"}
- {"criterion_text":"- Protocol-defined measurable disease"}
- {"criterion_text":"- Stable Eastern Cooperative Oncology Group Performance Status of 0 to 1"}
- {"criterion_text":"- Adequate organ function"}
- {"criterion_text":"- Female 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 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment"}
- {"criterion_text":"- Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab"}
- {"criterion_text":"- Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min (Sub-studies 1, 3 and 4)"}
- {"criterion_text":"- Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression (Sub-study 2)"}
Exclusion criteria
- {"criterion_text":"- Treatment-naive B-cell malignancies, except for patients in Substudy 1 Cohorts 5 and 6."}
- {"criterion_text":"- Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Sub-studies 3 and 4)"}
- {"criterion_text":"- All participants with a prior allogeneic stem cell transplant (Sub-studies 3 and 4)"}
- {"criterion_text":"- Unable to comply with the requirements of the protocol"}
- {"criterion_text":"- Active leptomeningeal disease or uncontrolled, untreated brain metastasis"}
- {"criterion_text":"- Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively"}
- {"criterion_text":"- Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening"}
- {"criterion_text":"- Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent (Sub-studies 1 and 2)"}
- {"criterion_text":"- Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab"}
- {"criterion_text":"- Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) (Sub-study 1)"}
- {"criterion_text":"- Participants who discontinued prior zanubrutinib treatment due to intolerance (Sub-study 2)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of patients with dose-limiting toxicities (Part 1a)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients with treatment-emergent adverse events (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients with treatment-related adverse events (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients with serious adverse events (Part 1a, part 1b)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response (DOR) (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time-to-response (TTR) (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Derived PK parameters of BGB-16673 (Part 1a)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Plasma concentration data (Part 1a, part 1b)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 271
- Recruitment Window Months
- 43
- Consent Approach
- Participants must sign an informed consent form (ICF) and be capable of giving written informed consent. Subject information sheets and ICFs are provided for the main study and substudy-specific ICFs; documentation includes versions in German, Italian and Polish. No paediatric assent procedures are applicable because paediatric subjects are excluded.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 99
Germany
- Earliest CTIS Part Ii Submission Date
- 17-08-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 249
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Frank Kroschinsky
- Principal Investigator Email
- xxx@ukdd.de
- Contact Person Name
- Frank Kroschinsky
- Contact Person Email
- xxx@ukdd.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Comprehensive Cancer Center Ulm
- Principal Investigator Name
- Eugen Tausch
- Principal Investigator Email
- xxx@uniklinik-ulm.de
- Contact Person Name
- Eugen Tausch
- Contact Person Email
- xxx@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Hämatologie und internistische Onkologie
- Principal Investigator Name
- Ulf Schnetzke
- Principal Investigator Email
- xxx@med.uni-jena.de
- Contact Person Name
- Ulf Schnetzke
- Contact Person Email
- xxx@med.uni-jena.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Medical Department II
- Principal Investigator Name
- Christiane Pott
- Principal Investigator Email
- xxx@med2.uni-kiel.de
- Contact Person Name
- Christiane Pott
- Contact Person Email
- xxx@med2.uni-kiel.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik, Innere Medizin II
- Principal Investigator Name
- Stefan Wirths
- Principal Investigator Email
- xxx@med.uni-tuebingen.de
- Contact Person Name
- Stefan Wirths
- Contact Person Email
- xxx@med.uni-tuebingen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 277
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Experimental Therapeutics Unit and Lymphoma Unit
- Principal Investigator Name
- Carmelo Carlo-Stella
- Principal Investigator Email
- carmelo.carlostella@hunimed.eu
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O.C. Ematologia
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Ematologia Oncologica e Trapianto di Cellule Staminali
- Principal Investigator Name
- Antonio Pinto
- Principal Investigator Email
- a.pinto@istitutotumori.na.it
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.na.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- S.C. Ematologia e UTMO
- Principal Investigator Name
- Anna Maria Frustaci
- Principal Investigator Email
- annamaria.frustaci@ospedaleniguarda.it
- Contact Person Name
- Anna Maria Frustaci
- Contact Person Email
- annamaria.frustaci@ospedaleniguarda.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Hematology Unit
- Principal Investigator Name
- Carlo Visco
- Principal Investigator Email
- carlo.visco@univr.it
- Contact Person Name
- Carlo Visco
- Contact Person Email
- carlo.visco@univr.it
Poland
- Earliest CTIS Part Ii Submission Date
- 02-09-2025
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 245
- Number Of Sites
- 5
- Number Of Participants
- 36
Sites
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
- Principal Investigator Name
- Janusz Hałka
- Principal Investigator Email
- janusz.halka@poliklinika.net
- Contact Person Name
- Janusz Hałka
- Contact Person Email
- janusz.halka@poliklinika.net
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- hematoonkologia@usk1.lublin.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- hematoonkologia@usk1.lublin.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Chłonnego
- Principal Investigator Name
- Ewa Paszkiewicz-Kozik
- Principal Investigator Email
- ewa.paszkiewicz-kozik@nio.gov.pl
- Contact Person Name
- Ewa Paszkiewicz-Kozik
- Contact Person Email
- ewa.paszkiewicz-kozik@nio.gov.pl
- Site Name
- Szpital Wojewodzki W Opolu Sp. z o.o.
- Department Name
- Oddział Kliniczny Hematologii, Onkologii Hematologicznej i Chorób Wewnętrznych
- Principal Investigator Name
- Dariusz Woszczyk
- Principal Investigator Email
- xx@szpital.opole.pl
- Contact Person Name
- Dariusz Woszczyk
- Contact Person Email
- xx@szpital.opole.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Michał Taszner
- Principal Investigator Email
- mtaszner@uck.gda.pl
- Contact Person Name
- Michał Taszner
- Contact Person Email
- mtaszner@uck.gda.pl
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- Distribution of Clinical Safety Reports
- Name
- 4g Clinical LLC
- Responsibilities
- code 3
- Name
- Iqvia Laboratories Limited
- Responsibilities
- code 4
- Name
- Medidata Solutions Inc.
- Responsibilities
- code 4
Third parties
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"China","full_name":"Wuxi Biologics (Shanghai) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Local supply of rescue medication","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Distribution of Clinical Safety Reports","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ledger Run Inc.","duties_or_roles":"Site payments","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BGB-16673
- Active Substance
- BGB-16673
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- BGB-11417
- Active Substance
- N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3- NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5- YL)OXY]BENZAMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- Zanubrutinib
- Active Substance
- ZANUBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- Mosunetuzumab
- Active Substance
- MOSUNETUZUMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Investigational Product Name
- Columvi (glofitamab)
- Active Substance
- GLOFITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation number EU/1/23/1742/002
- Orphan Designation
- Yes
- Investigational Product Name
- Gazyvaro (obinutuzumab)
- Active Substance
- OBINUTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation number EU/1/14/937/001
- Orphan Designation
- Yes
- Combination Treatment
- Yes
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