A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (CaDAnCe-101)

A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

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)

Study Overview

• Status: Recruiting
• Conditions: Follicular Lymphoma; Waldenström Macroglobulinemia; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Small Lymphocytic Lymphoma; B-cell Malignancy
• Intervention / Treatment: Drug: BGB-16673

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 645
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Study Director, MD
• Study Contact Backup: Name: BeOne Medicines; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, NSW 2139
      • Recruiting
      • Concord Repatriation General Hospital
    • Waratah, New South Wales, Australia, NSW 2298
      • Recruiting
      • Calvary Mater Newcastle
  • Queensland
    • Woolloongabba, Queensland, Australia, QLD 4102
      • Recruiting
      • Princess Alexandra Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, VIC 3065
      • Recruiting
      • St Vincents Hospital Melbourne
    • Heidelberg, Victoria, Australia, VIC 3084
      • Recruiting
      • Austin Health
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, VIC 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
    • West Perth, Western Australia, Australia, WA 6005
      • Recruiting
      • Perth Blood Institute
• Brazil
  • Brasília, Brazil, 70200-730
    • Recruiting
    • Hospital Sirio Libanes Brasilia
  • Caxias do Sul, Brazil, 95070-560
    • Completed
    • Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
  • Porto Alegre, Brazil, 90160-093
    • Completed
    • Hospital Ernesto Dornelles
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01321-001
    • Recruiting
    • Real E Benemerita Associacao Portuguesa de Sao Paulo
  • São Paulo, Brazil, 01409-001
    • Recruiting
    • Hospital Nove de Julho Dasa
  • São Paulo, Brazil, 01327-001
    • Completed
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 01401-004
    • Recruiting
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
• Canada
  • Québec, Canada, G1J 1Z4
    • Recruiting
    • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur Je Child Comprehensive Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • British Columbia Cancer Agency the Vancouver Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 630014
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Recruiting
      • Guangxi Medical University Cancer Hospital Wuxiang Branch
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • Recruiting
      • The Fourth Hospital of Hebei Medical University East Branch
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Yichang, Hubei, China, 443001
      • Recruiting
      • Yichang Central Peoples Hospitaljiangnan Branch
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 332000
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Xianghu
  • Liaoning
    • Shenyang, Liaoning, China, 110134
      • Recruiting
      • Shengjing Hospital of China Medical Universityshenbei Branch
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin Municipality, China, 301617
      • Recruiting
      • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• France
  • Bordeaux, France, 33000
    • Recruiting
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • ClermontFerrand, France, 63100
    • Recruiting
    • Hopital Estaing
  • Créteil, France, 94000
    • Recruiting
    • CHU Henri Mondor
  • Lille, France, 59000
    • Recruiting
    • Hopital Claude Huriez Chu Lille
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Montpellier, France, 34090
    • Recruiting
    • Chu Montpellier Hopital Saint Eloi
  • Paris, France, 75013
    • Recruiting
    • Hopital de la Pitie Salpetriere
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
• Georgia
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Arensia Exploratory Medicine Llc
• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • Uniklinik Koeln (Aoer)
  • Dresden, Germany, 01307
    • Recruiting
    • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitares Krebszentrum Leipzig
  • Lübeck, Germany, 23538
    • Recruiting
    • Universitaetsklinikum Schleswig Holstein Campus Luebeck
  • Mainz, Germany, 55131
    • Recruiting
    • Klinikum Johannes Gutenberg Universitaet Mainz
  • München, Germany, 81377
    • Recruiting
    • Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20162
    • Recruiting
    • Niguarda Cancer Center Division of Hematology
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli
  • Verona, Italy, 37134
    • Recruiting
    • Centroricerche Cliniche Di Verona Srl
• Japan
  • Yokohama, Japan, 221-0855
    • Recruiting
    • Yokohama Municipal Citizens Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center Hospital Clinical Oncology
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Tokyo
    • Kotoku, Tokyo, Japan, 135-8550
      • Recruiting
      • Cancer Institute Hospital of Jfcr
• Moldova
  • Chisinau, Moldova, 2025
    • Active, not recruiting
    • The Institute of Oncology, Arensia Exploratory Medicine
• South Korea
  • Busan Gwang'yeogsi
    • BusanjinGu, Busan Gwang'yeogsi, South Korea, 47392
      • Recruiting
      • Inje University Busan Paik Hospital
    • Seogu, Busan Gwang'yeogsi, South Korea, 49241
      • Recruiting
      • Pusan National University Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall dHebron
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28033
    • Recruiting
    • Md Anderson Cancer Center Madrid Spain
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
• Sweden
  • Gothenburg, Sweden, 413 46
    • Recruiting
    • Sahlgrenska University Hospital Hematology
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Karolinska Universitetssjukhuset Solna
• Turkey (Türkiye)
  • Balçova, Turkey (Türkiye), 35330
    • Recruiting
    • Dokuz Eylül University
  • Kayseri, Turkey (Türkiye), 38030
    • Recruiting
    • Erciyes University
  • Sakarya, Turkey (Türkiye), 54100
    • Recruiting
    • Sakarya Training and Research Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Recruiting
    • Ondokuz Mayis University
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Edinburgh Cancer Centre
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St Jamess University Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Freeman Hospital
  • Newmarket, United Kingdom, CB8 7XN
    • Recruiting
    • Genesiscare Cambridge
  • Nottingham, United Kingdom, NG5 1PB
    • Recruiting
    • Nottingham University Hospitals NHS Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • Derriford Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0004
      • Recruiting
      • University of Alabama At Birmingham Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85054-4502
      • Completed
      • Mayo Clinic Phoenix
    • Scottsdale, Arizona, United States, 85258-4566
      • Recruiting
      • Honor Health Research Institute
    • Tucson, Arizona, United States, 85724-0001
      • Recruiting
      • University of Arizona Cancer Center
  • California
    • La Jolla, California, United States, 92093-1503
      • Recruiting
      • University of California San Diego (Ucsd) Moores Cancer Center
    • Palo Alto, California, United States, 94304-2205
      • Recruiting
      • Stanford Medicine
    • Santa Monica, California, United States, 90404-2023
      • Recruiting
      • UCLA Santa Monica Cancer Care
  • Colorado
    • Fort Collins, Colorado, United States, 80528-3413
      • Recruiting
      • Uchealth North
  • Florida
    • Jacksonville, Florida, United States, 32224-1865
      • Recruiting
      • Mayo Clinic Jacksonville
    • Miami, Florida, United States, 33140
      • Recruiting
      • Mount Sinai Medical Center Braman Comprehensive Cancer Center
    • Tampa, Florida, United States, 33606-3571
      • Recruiting
      • Tampa General Hospital Cancer Institute
  • Georgia
    • Augusta, Georgia, United States, 30912-0002
      • Recruiting
      • Augusta University
    • Newnan, Georgia, United States, 30265-8001
      • Recruiting
      • Southeastern Regional Medical Center
  • Illinois
    • Zion, Illinois, United States, 60099-2676
      • Completed
      • Midwestern Regional Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • Recruiting
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40207-4700
      • Active, not recruiting
      • Norton Cancer Institute Pavilion
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809-3738
      • Recruiting
      • Mary Bird Perkins Cancer Center
  • Maryland
    • Bethesda, Maryland, United States, 20817-7847
      • Recruiting
      • American Oncology Partners of Maryland Pa
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201-2013
      • Recruiting
      • Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic Rochester
  • Nevada
    • Las Vegas, Nevada, United States, 89169-3321
      • Recruiting
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • New York, New York, United States, 10065-6800
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Mskcc
    • New York, New York, United States, 10065-4870
      • Recruiting
      • Weill Cornell Medical College Newyork Presbyterian Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Tennesse Oncology Chattanooga Downtown
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, Pllc Nashville
  • Texas
    • Houston, Texas, United States, 77030-3907
      • Recruiting
      • MD Anderson Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109-4433
      • Recruiting
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
4. Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.
5. Measurable disease by radiographic assessment or serum IgM level (WM only)
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country 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/SLL participants, 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 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 breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion 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, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1b (Monotherapy Safety Expansion); Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673.	Drug: BGB-16673; Orally administered
Experimental: Part 1c (Additional Monotherapy Safety Expansion); Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies.	Drug: BGB-16673; Orally administered
Experimental: Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL); Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.	Drug: BGB-16673; Orally administered
Experimental: Part 1e (Japan-only Cohort); Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673.	Drug: BGB-16673; Orally administered
Experimental: Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies); Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.	Drug: BGB-16673; Orally administered
Experimental: Part 1a (Monotherapy Dose Escalation); Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), R/R follicular lymphoma (FL) Grades 1, 2, and 3a, R/R mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), R/R diffuse large B-cell lymphoma (DLBCL), R/R Richter's transformation (RT), and R/R Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673.	Drug: BGB-16673; Orally administered
Experimental: Phase 2 (Monotherapy Expansion); Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673.	Drug: BGB-16673; Orally administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Number of Participants with Adverse Events (AEs)	Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.	From the first dose of BGB-16673 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673	MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.	Approximately 28 days
Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673	RDFE of BGB-16673 alone will be determined based upon the MTD or MAD.	Approximately 3 years
Phase 2: Overall response rate (ORR)	Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM.	approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2: Overall Survival (OS)	OS is defined as the time from first study drug administration to the date of death due to any cause	approximately 3 years
Single dose and steady-state maximum observed plasma concentration (Cmax) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state minimum observed plasma concentration (Cmin) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state time to reach Cmax (tmax) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state area under the plasma concentration-time curve (AUC) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state apparent volume of distribution (Vz/F) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Single dose and steady-state accumulation ratios of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy		Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
Phase 2: Duration of Response (DOR)	DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is documented or death, whichever comes first as assessed by the investigator and the IRC.	approximately 3 years
Phase 1: Overall response rate (ORR)	Defined as the percentage of participants whose best overall response is partial response or better, as assessed by the investigator and evaluated according to the following criteria: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for R/R CLL, the International Workshop on Waldenström's Macroglobulinemia (IWWM-11) criteria for R/R WM (in participants with WM, this is also referred to as major response rate), and the Lugano criteria for R/R NHL.	approximately 3 years
Phase 1: Response Rate in Participants with R/R CLL/SLL	Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by investigators.	approximately 3 years
Phase 1: Overall Response Rate in Participants with R/R WM	Defined as the percentage of participants with R/R WM who have a response rate of minor response or better.	approximately 3 years
Phase 2: Recommended Phase 2 Dose (RP2D)	The Recommended Phase 2 Dose (RP2D) is determined by the sponsor based on the Safety Monitoring Committee's recommendations, taking into account the overall clinical safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data.	approximately 3 years
Phase 2: Number of Participants with AEs	Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, graded according to the NCI-CTCAE v5.0.	From the first dose of BGB-16673 in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
Phase 2: ORR in Participants with CLL/SLL assessed by investigators	Defined as the percentage of participants with CLL/SLL with a best overall response of PR or better, as determined by investigators.	approximately 3 years
Phase 2: Major Response Rate for Participants with WM assessed by investigator	Defined as the percentage of participants with WM whose best overall response is PR or better, as determined by investigators using the IWWM-11 criteria.	approximately 3 years
Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC	Defined as the percentage of participants who achieve at least a minor response (MR) or a more favorable outcome, as assessed by investigators for participants with R/R WM.	approximately 3 years
Phase 2: Rate of Very Good Partial Response (VGPR) or Better in Participants with WM Assessed by Investigator and IRC	Defined as the percentage of participants with R/R WM with best response of VGPR or better as determined by IRC and investigator.	approximately 3 years
Phase 2: Response Rate in Participants with R/R CLL/SLL Assessed by Investigator and IRC	Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by IRC and investigator.	approximately 3 years
Phase 2: Time to Overall Response (TTOR)	TTOR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator	approximately 3 years
Phase 2: Time to Major Response (TTMR) in Participants with WM	Defined as the time from the date of treatment initiation to the date of first response of PR or better in participants with R/R WM.	approximately 3 years
Phase 2: Time to Response in Participants with R/R CLL/SLL Assessed by Investigator and IRC	Defined as the time to first response based on best overall response of better than stable disease, per IRC and investigator.	approximately 3 years
Phase 2: Time to Response in Participants with WM Assessed by Investigator and IRC	Defined as the time to first response based on best overall response of minor response or better, per IRC and investigator.	approximately 3 years
Phase 2: Time to Next Treatment (TTNT)	Defined as the time from the treatment start date to the initiation of subsequent anticancer therapy.	approximately 3 years
Phase 2: Progression- Free Survival (PFS)	PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC for R/R CLL/SLL and R/R WM and by the investigator for all participants.	approximately 3 years
Phase 2: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)	Mean change from baseline in the NFlymSI-18 subscales of disease-related symptoms (DRSP) and 'treatment side effects' for participants with R/R MCL and participants with R/R WM. The NFlymSI-18 is an 18-item patient-reported outcome (PRO) tool specifically designed to assess symptoms and treatment impacts in patients with non-Hodgkin lymphoma.	Baseline and day 1 of Weeks 5, 13, 25, and 37
Single dose and steady-state elimination half-life (T1/2) of BGB-16673		Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort)	Number of Japanese participants in Part 1e with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0.	From the first dose of BGB-16673 in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire	Mean change from baseline in the 'physical well-being' and 'functional well-being' subscales of the FACT-Leu for participants with R/R CLL/SLL. FACT-Leu is a 44-item PRO questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients.	Baseline and day 1 of Weeks 5, 13, 25, and 37

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: BGB-16673-101; 2022-502157-33-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No