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
2 other identifiers
interventional
614
16 countries
127
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2021
Longer than P75 for phase_1
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
April 22, 2026
April 1, 2026
5.1 years
August 9, 2021
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (30)
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 time to reach half of Cmax (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.
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.
- +25 more secondary outcomes
Study Arms (7)
Part 1a (Monotherapy Dose Escalation)
EXPERIMENTALDose 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.
Part 1b (Monotherapy Safety Expansion)
EXPERIMENTALParticipants 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.
Part 1c (Additional Monotherapy Safety Expansion)
EXPERIMENTALAdditional 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.
Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL)
EXPERIMENTALParticipants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.
Part 1e (Japan-only Cohort)
EXPERIMENTALJapanese 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.
Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)
EXPERIMENTALParticipants 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.
Phase 2 (Monotherapy Expansion)
EXPERIMENTALCohorts 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.
Interventions
Orally administered
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- 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.
- Measurable disease by radiographic assessment or serum IgM level (WM only)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- 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).
You may not qualify if:
- 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.
- Requires ongoing systemic treatment for any other malignancy
- Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
- 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
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (127)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004, United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85054-4502, United States
Honor Health Research Institute
Scottsdale, Arizona, 85258-4566, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724-0001, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503, United States
Stanford Medicine
Palo Alto, California, 94304-2205, United States
UCLA Santa Monica Cancer Care
Santa Monica, California, 90404-2023, United States
Uchealth North
Fort Collins, Colorado, 80528-3413, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140-2840, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606-3571, United States
Augusta University
Augusta, Georgia, 30912-0002, United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265-8001, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099-2676, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, 20817-7847, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10065-4870, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433, United States
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Perth Blood Institute
West Perth, Western Australia, WA 6005, Australia
Hospital Sirio Libanes Brasilia
Brasília, 70200-730, Brazil
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, 95070-560, Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-093, Brazil
Real E Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, 01321-001, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004, Brazil
Hospital Nove de Julho Dasa
São Paulo, 01409-001, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201, China
The Fourth Hospital of Hebei Medical University East Branch
Shijiazhuang, Hebei, 050035, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Yichang Central Peoples Hospitaljiangnan Branch
Yichang, Hubei, 443001, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000, France
Hopital Estaing
Clermontferrand, 63100, France
Chu Henri Mondor
Créteil, 94000, France
Hopital Claude Huriez Chu Lille
Lille, 59000, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Hopital de La Pitie Salpetriere
Paris, 75013, France
Centre Henri Becquerel
Rouen, 76038, France
Arensia Exploratory Medicine Llc
Tbilisi, 0112, Georgia
Uniklinik Koeln (Aoer)
Cologne, 50937, Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307, Germany
Universitares Krebszentrum Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Lübeck, 23538, Germany
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, 55131, Germany
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
München, 81377, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Niguarda Cancer Center Division of Hematology
Milan, 20162, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Centroricerche Cliniche Di Verona Srl
Verona, 37134, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, 464-8681, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855, Japan
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025, Moldova
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, 47392, South Korea
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, 49241, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Md Anderson Cancer Center Madrid Spain
Madrid, 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Sahlgrenska University Hospital Hematology
Gothenburg, 413 46, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Dokuz Eylul University
Balçova, 35330, Turkey (Türkiye)
Erciyes University
Kayseri, 38030, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, 55200, Turkey (Türkiye)
Edinburgh Cancer Centre
Edinburgh, EH4 2XU, United Kingdom
St Jamess University Hospital
Leeds, LS9 7TF, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Director, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 16, 2021
Study Start
September 13, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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