A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Last updated: March 21, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Waldenstrom Macroglobulinemia

Leukemia

Treatment

BGB-16673

Clinical Study ID

NCT05006716
BGB-16673-101
2022-502157-33-00
  • Ages > 18
  • All Genders

Study Summary

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Eligibility Criteria

Inclusion

Inclusion Criteria :

  1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unlessotherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) , FollicularLymphoma (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia andsmall lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuselarge B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation toDLBCL.

  2. Participants who have previously received a covalently-binding Bruton´s tyrosinekinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatmentwith the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation isintolerance).

  3. For dose-finding and dose-expansion, participants who had previously received acovalently-binding BTK inhibitor as monotherapy or in combination with otheranticancer agents are eligible for the study if they meet any of the followingcriteria: discontinued the previous BTK inhibitor due to disease progression,experienced disease progression after completing treatment with a BTK inhibitor ordiscontinued the BTK inhibitor due to toxicity or intolerance.

  4. Measurable disease by radiographic assessment or serum IgM level (WM only)

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

  6. Participants enrolling in the dose finding phase of the study may be previouslytreated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis andcountry of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLLparticipants, in addition to being treated with a BTKi in a prior line of therapy,must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).

Exclusion

Exclusion Criteria:

  1. Prior malignancy (other than the disease under study) within the past 2 years,except in situ malignancies that have been curatively resected, localized breastcancer treated with curative intent with no evidence of breast active disease formore than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, orany other cancer treated with curative intent, not on adjuvant treatment, and in theopinion of the investigator is unlikely to recur.

  2. Requires ongoing systemic treatment for any other malignancy

  3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)corticosteroid treatment.

  4. Current or history of central nervous system involvement including the brain, spinalcord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, orbiopsy) by B-cell malignancy, regardless of whether participants had receivedtreatment for central nervous system disease

  5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkittlymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma,Castleman disease, post-transplant lymphoproliferative disorders, hairy cellleukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of thecentral nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associatedwith chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma,intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusionlymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with featuresintermediate between DLBCL and classical Hodgkin lymphoma, or history of orcurrently suspected transformation of an indolent lymphoma to an aggressivehistology (except for participants with Richter Transformation to DLBCL are eligiblefor Part 1a, 1c, or Phase 2 and participants with history of follicular lymphomatransforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 621
Treatment Group(s): 1
Primary Treatment: BGB-16673
Phase: 1/2
Study Start date:
September 13, 2021
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peninsula Private Hospital

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Institute

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Perth Blood Institute

    West Perth, Western Australia 6005
    Australia

    Active - Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasilia, 70200-730
    Brazil

    Active - Recruiting

  • Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul

    Caxias do Sul, 95070-560
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

    Active - Recruiting

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90850-170
    Brazil

    Active - Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz

    Sao Paulo, 04829-310
    Brazil

    Active - Recruiting

  • Hospital Nove de Julho Dasa

    Sao Paulo, 01409-902
    Brazil

    Active - Recruiting

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 01401-002
    Brazil

    Active - Recruiting

  • Real E Benemerita Associacao Portuguesa de Sao Paulo

    Sao Paulo, 01321-001
    Brazil

    Active - Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Active - Recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043260
    Brazil

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  • Tom Baker Cancer Center

    Calgary, Alberta T2N 4N2
    Canada

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  • Cross Cancer Institute

    Edmonton, Alberta T6G1Z2
    Canada

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  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

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  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C9
    Canada

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  • Arthur Je Child Comprehensive Cancer Centre

    Calgary, T2N 5G2
    Canada

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  • Chu de Quebec Universite Laval

    Quebec, G1J 1Z4
    Canada

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  • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

    Quebec, G1J 1Z4
    Canada

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  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076
    France

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  • Hopital Estaing

    Clermont Ferrand, 63003
    France

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  • Chu Henri Mondor

    Creteil, 94000
    France

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  • Hopital Claude Huriez Chu Lille

    Lille, 59000
    France

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  • Centre Leon Berard

    Lyon Cedex, 69373
    France

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  • Institut Paoli Calmettes

    Marseille, 13009
    France

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  • Chu Montpellier Hopital Saint Eloi

    Montpellier Cedex, 34295
    France

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  • Hopital de La Pitie Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • Centre Henri Becquerel

    Rouen Cedex, 76038
    France

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  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112
    Georgia

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  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307
    Germany

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  • Uniklinik Koln (Aor)

    Koln, 50937
    Germany

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  • Universitares Krebszentrum Leipzig

    Leipzig, 04103
    Germany

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  • Universitaetsklinikum Schleswig Holstein Campus Luebeck

    Luebeck, 23538
    Germany

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  • Klinikum Johannes Gutenberg Universitaet Mainz

    Mainz, 55131
    Germany

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  • Klinikum Grosshadern Ludwig Maximilians Universitat Munchen

    Munich, 81377
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  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081
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  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138
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  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

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    Milano, 20141
    Italy

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  • Niguarda Cancer Center Division of Hematology

    Milano, 20162
    Italy

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  • Ospedale San Raffaele

    Milano, 20132
    Italy

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  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

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  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134
    Italy

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  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi 464-8681
    Japan

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  • Chiba Cancer Center

    Chibashi, Chiba 260-8717
    Japan

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  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizens Hospital

    Yokohamashi, 221-0855
    Japan

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  • Inje University Busan Paik Hospital

    Busan, Busan Gwang'yeogsi 47392
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, Busan Gwang'yeogsi 49241
    Korea, Republic of

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  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
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  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

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  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

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  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

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  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

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  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025
    Moldova, Republic of

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  • Hospital Universitario Vall Dhebron

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  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

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  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Md Anderson Cancer Center Madrid Spain

    Madrid, 28033
    Spain

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  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222
    Spain

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  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Sahlgrenska University Hospital Hematology

    Goteborg, 41345
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Uppsala Akademiska Sjukhus

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Ankara University

    Ankara, 06620
    Turkey

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Research and Training Hospital

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Dokuz Eylul University

    Izmir, 35340
    Turkey

    Active - Recruiting

  • Erciyes University

    Kayseri, 38030
    Turkey

    Active - Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100
    Turkey

    Active - Recruiting

  • Ondokuz Mayis University

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Edinburgh Cancer Centre

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Active - Recruiting

  • St Jamess University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    NewCastle Upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB
    United Kingdom

    Active - Recruiting

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Western Regional Medical Center, Llc

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Mayo Clinic (Phoenix)

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona 85254
    United States

    Active - Recruiting

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona 85724-5024
    United States

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • University of California San Diego (Ucsd) Moores Cancer Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Valkyrie Clinical Trials, Inc.

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • UCLA Santa Monica Cancer Care

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Stanford Medicine

    Stanford, California 94305
    United States

    Active - Recruiting

  • Uchealth North

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Mayo Clinic (Jacksonville)

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Tampa General Hospital Cancer Institute

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Southeastern Regional Medical Center

    Newnan, Georgia 30265
    United States

    Active - Recruiting

  • Midwestern Regional Medical Center

    Zion, Illinois 60099
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Norton Cancer Institute Pavilion

    Louisville, Kentucky 40207
    United States

    Completed

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland Pa

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Mayo Clinic (Rochester)

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Grand Island, Nebraska 68803
    United States

    Completed

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York 10021
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • Tennesse Oncology Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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