Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05006716

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

Led by BeOne Medicines · Updated on 2026-05-11

614

Participants Needed

128

Research Sites

424 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of marginal zone lymphoma, relapsed/refractory follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, relapsed/refractory diffuse large B-cell lymphoma, or Richter's transformation to diffuse large B-cell lymphoma
  • Prior treatment with a covalently-binding Bruton tyrosine kinase (BTK) inhibitor for at least 8 weeks unless discontinued due to intolerance
  • Previous BTK inhibitor treatment discontinued due to disease progression, toxicity, or intolerance
  • Measurable disease by radiographic assessment or serum IgM level for Waldenström macroglobulinemia
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Participants in dose finding phase may be BTK inhibitor naive or treated; mantle cell lymphoma participants in expansion phase must have prior BTK inhibitor treatment; chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have prior BTK and Bcl-2 inhibitor treatment in expansion phase
Not Eligible

You will not qualify if you...

  • Prior malignancy within the past 2 years except certain in situ cancers or curatively treated localized cancers without evidence of active disease
  • Ongoing systemic treatment for any other malignancy
  • Ongoing systemic corticosteroid treatment at or above 10 mg/day prednisone or equivalent
  • Current or history of central nervous system involvement by B-cell malignancy
  • Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, AIDS-related B-cell lymphoma, Castleman disease, or other specified aggressive or rare lymphomas
  • History or suspicion of transformation of indolent lymphoma to aggressive histology except specific allowed cases of Richter Transformation or follicular lymphoma transforming to non-GCB diffuse large B-cell lymphoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 128 locations

1

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States, 35294-0004

Actively Recruiting

2

Mayo Clinic Phoenix

Phoenix, Arizona, United States, 85054-4502

Completed

3

Honor Health Research Institute

Scottsdale, Arizona, United States, 85258-4566

Actively Recruiting

4

University of Arizona Cancer Center

Tucson, Arizona, United States, 85724-0001

Actively Recruiting

5

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, United States, 92093-1503

Actively Recruiting

6

Stanford Medicine

Palo Alto, California, United States, 94304-2205

Actively Recruiting

7

UCLA Santa Monica Cancer Care

Santa Monica, California, United States, 90404-2023

Actively Recruiting

8

Uchealth North

Fort Collins, Colorado, United States, 80528-3413

Actively Recruiting

9

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224-1865

Actively Recruiting

10

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States, 33140-2840

Actively Recruiting

11

Tampa General Hospital Cancer Institute

Tampa, Florida, United States, 33606-3571

Actively Recruiting

12

Augusta University

Augusta, Georgia, United States, 30912-0002

Actively Recruiting

13

Southeastern Regional Medical Center

Newnan, Georgia, United States, 30265-8001

Actively Recruiting

14

Midwestern Regional Medical Center

Zion, Illinois, United States, 60099-2676

Completed

15

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242-1009

Actively Recruiting

16

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809-3738

Actively Recruiting

17

American Oncology Partners of Maryland Pa

Bethesda, Maryland, United States, 20817-7847

Actively Recruiting

18

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

19

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201-2013

Actively Recruiting

20

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905-0001

Actively Recruiting

21

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169-3321

Actively Recruiting

22

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Actively Recruiting

23

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

24

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, United States, 10065-4870

Actively Recruiting

25

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States, 10065-6800

Actively Recruiting

26

Tennesse Oncology Chattanooga Downtown

Chattanooga, Tennessee, United States, 37404

Actively Recruiting

27

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States, 37203

Actively Recruiting

28

Md Anderson Cancer Center

Houston, Texas, United States, 77030-3907

Actively Recruiting

29

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

30

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109-4433

Actively Recruiting

31

Concord Repatriation General Hospital

Concord, New South Wales, Australia, NSW 2139

Actively Recruiting

32

Calvary Mater Newcastle

Waratah, New South Wales, Australia, NSW 2298

Actively Recruiting

33

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

34

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia, VIC 3065

Actively Recruiting

35

Austin Health

Heidelberg, Victoria, Australia, VIC 3084

Actively Recruiting

36

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Actively Recruiting

37

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

Actively Recruiting

38

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Actively Recruiting

39

Perth Blood Institute

West Perth, Western Australia, Australia, WA 6005

Actively Recruiting

40

Hospital Sirio Libanes Brasilia

Brasília, Brazil, 70200-730

Actively Recruiting

41

Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul

Caxias do Sul, Brazil, 95070-560

Completed

42

Hospital Erasto Gaertner

Curitiba, Brazil, 81520-060

Actively Recruiting

43

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Actively Recruiting

44

Hospital Ernesto Dornelles

Porto Alegre, Brazil, 90160-093

Completed

45

Real E Benemerita Associacao Portuguesa de Sao Paulo

São Paulo, Brazil, 01321-001

Actively Recruiting

46

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil, 01327-001

Completed

47

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil, 01401-004

Actively Recruiting

48

Hospital Nove de Julho Dasa

São Paulo, Brazil, 01409-001

Actively Recruiting

49

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil, 05652-900

Actively Recruiting

50

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

51

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

52

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

53

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

54

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

Québec, Canada, G1J 1Z4

Actively Recruiting

55

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

56

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 630014

Actively Recruiting

57

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

58

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

59

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China, 530201

Actively Recruiting

60

The Fourth Hospital of Hebei Medical University East Branch

Shijiazhuang, Hebei, China, 050035

Actively Recruiting

61

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

62

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

63

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

64

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

65

Yichang Central Peoples Hospitaljiangnan Branch

Yichang, Hubei, China, 443001

Actively Recruiting

66

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

67

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

68

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China, 332000

Actively Recruiting

69

Shengjing Hospital of China Medical Universityshenbei Branch

Shenyang, Liaoning, China, 110134

Actively Recruiting

70

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

71

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

72

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

Tianjin, Tianjin Municipality, China, 301617

Actively Recruiting

73

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China, 310002

Actively Recruiting

74

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

75

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

76

Hopital Estaing

Clermontferrand, France, 63100

Actively Recruiting

77

Chu Henri Mondor

Créteil, France, 94000

Actively Recruiting

78

Hopital Claude Huriez Chu Lille

Lille, France, 59000

Actively Recruiting

79

Centre Leon Berard

Lyon, France, 69373

Actively Recruiting

80

Institut Paoli Calmettes

Marseille, France, 13009

Actively Recruiting

81

Chu Montpellier Hopital Saint Eloi

Montpellier, France, 34090

Actively Recruiting

82

Hopital de La Pitie Salpetriere

Paris, France, 75013

Actively Recruiting

83

Centre Henri Becquerel

Rouen, France, 76038

Actively Recruiting

84

Arensia Exploratory Medicine Llc

Tbilisi, Georgia, 0112

Actively Recruiting

85

Uniklinik Koeln (Aoer)

Cologne, Germany, 50937

Actively Recruiting

86

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, Germany, 01307

Actively Recruiting

87

Universitares Krebszentrum Leipzig

Leipzig, Germany, 04103

Actively Recruiting

88

Universitaetsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Germany, 23538

Actively Recruiting

89

Klinikum Johannes Gutenberg Universitaet Mainz

Mainz, Germany, 55131

Actively Recruiting

90

Klinikum Grosshadern Ludwig Maximilians Universitat Munchen

München, Germany, 81377

Actively Recruiting

91

Universitaetsklinikum Ulm

Ulm, Germany, 89081

Actively Recruiting

92

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy, 40138

Actively Recruiting

93

Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

94

Istituto Europeo Di Oncologia

Milan, Italy, 20141

Actively Recruiting

95

Niguarda Cancer Center Division of Hematology

Milan, Italy, 20162

Actively Recruiting

96

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Actively Recruiting

97

Centroricerche Cliniche Di Verona Srl

Verona, Italy, 37134

Actively Recruiting

98

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

99

Chiba Cancer Center

Chiba, Chiba, Japan, 260-8717

Actively Recruiting

100

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

101

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan, 135-8550

Actively Recruiting

102

Yokohama Municipal Citizens Hospital

Yokohama, Japan, 221-0855

Actively Recruiting

103

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova, 2025

Active, Not Recruiting

104

Inje University Busan Paik Hospital

BusanjinGu, Busan Gwang'yeogsi, South Korea, 47392

Actively Recruiting

105

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea, 49241

Actively Recruiting

106

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Actively Recruiting

107

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea, 06591

Actively Recruiting

108

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

109

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

110

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea, 05505

Actively Recruiting

111

Hospital Universitario Vall Dhebron

Barcelona, Spain, 08035

Actively Recruiting

112

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Actively Recruiting

113

Md Anderson Cancer Center Madrid Spain

Madrid, Spain, 28033

Actively Recruiting

114

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

115

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

116

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain, 28222

Actively Recruiting

117

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

118

Sahlgrenska University Hospital Hematology

Gothenburg, Sweden, 413 46

Actively Recruiting

119

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden, 171 76

Actively Recruiting

120

Dokuz Eylul University

Balçova, Turkey (Türkiye), 35330

Actively Recruiting

121

Erciyes University

Kayseri, Turkey (Türkiye), 38030

Actively Recruiting

122

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye), 54100

Actively Recruiting

123

Ondokuz Mayis University

Samsun, Turkey (Türkiye), 55200

Actively Recruiting

124

Edinburgh Cancer Centre

Edinburgh, United Kingdom, EH4 2XU

Actively Recruiting

125

St Jamess University Hospital

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

126

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

127

Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom, NG5 1PB

Actively Recruiting

128

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Actively Recruiting

Loading map...

Research Team

B

BeOne Medicines

CONTACT

S

Study Director, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

7

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here