B-cell MalignancyPhase 1/2NCT05294731
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
A Phase 1/2 study testing Tacabrutideg in people with B-cell Malignancy and Non-Hodgkin Lymphoma, run by BeOne Medicines at 29 sites in China.
Trial summary
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Tacabrutideg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 29 sitesChina
- Study dates
- 6 May 2022to 31 Jan 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate hematologic, coagulation, renal, pancreatic, and hepatic function, and measurable disease according to disease-specific criteria, as applicable
- Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
- Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
- Highly effective method of birth control during study treatment period, and for ≥ 30 days after the last dose of the study drug
Who cannot join
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
- Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
- Current or history of central nervous involvement
- Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 29 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
- Recruiting
Beijing Chao Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, 400037
- Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
- Recruiting
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, 510120
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang
Hangzhou, Zhejiang, 311121
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
- Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
- Recruiting
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, 330029
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Recruiting
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
- Recruiting
Nanyang Central Hospital
Nanyang, Henan, 473000
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266031
- Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
- Recruiting
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Read the detailed description
A B-cell malignancy is a type of cancer that starts in white blood cells called B-cells. These cancers can affect the lymph nodes, bone marrow, blood, and spleen. Examples include marginal zone lymphoma, follicular lymphoma, non-Hodgkin lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, and diffuse large B cell lymphoma.
Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.
The purpose of this study is to test whether tacabrutideg is safe and if it can help treat B-cell malignancies. The main goals are to ensure the drug is safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.
This study consists of two parts: dose escalation and dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose or doses identified from dose escalation. The study is open label, which means that the participants and the study doctors will know what treatment is received.
This study will enroll approximately 146 participants with B-cell malignancies at multiple centers worldwide.
The approximate duration of participation for each participant is up to 3 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
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.
- Conditions
- B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia, Marginal Zone Lymphoma
- Being tested
- Tacabrutideg
- Keywords
- B-cell Malignancy, MZL, FL, DLBCL, Richter's Transformation, CDAC, BTK, degrader, BGB-16673
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacabrutidegDrug
Also called BGB-16673
Orally administered
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Monotherapy Dose Escalation | Experimental | Tacabrutideg will be orally administered. Receives: Drug: Tacabrutideg |
| Phase 1b Monotherapy Safety Expansion | Experimental | Tacabrutideg will be orally administered. Receives: Drug: Tacabrutideg |
| Phase 2 Monotherapy Dose Expansion | Experimental | Tacabrutideg will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1. Receives: Drug: Tacabrutideg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Measured: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
Phase 1: Recommended Phase 2 dose (RP2D) of Tacabrutideg
As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.
Measured: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
Phase 1a: Maximum tolerated dose (MTD) of Tacabrutideg
The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).
Measured: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
ORR is defined as the percentage of participants with partial response or better according to the Investigators assessment and as determined by Lugano criteria.
Measured: Up to approximately 3 years
Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
ORR is defined as the percentage of participants with partial response or better as assessed by the Independent Review Committee (IRC) and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL
Measured: Up to approximately 3 years
Secondary outcomes (28)
Maximum observed plasma concentration (Cmax) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Minimum observed plasma concentration (Cmin) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent terminal elimination half-life (t1/2) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Area under the plasma-concentration curve (AUC) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent oral clearance (CL/F) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent volume of distribution (Vz/F) After a Single Dose of Tacabrutideg
Measured: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Maximum observed steady state plasma concentration (Css,max) of Tacabrutideg
Measured: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Time to reach maximum observed steady state plasma concentration (Tss,max) of Tacabrutideg
Measured: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Minimum observed steady state plasma concentration (Css,min) of Tacabrutideg
Measured: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Steady state area under the plasma concentration-time curve (AUC) of Tacabrutideg
Measured: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Accumulation ratios of Cmax and AUC of Tacabrutideg
Measured: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose up to 8 hours post-dose; Phase 1b: Week 1 and Week 5 pre-dose up to 6 hours post-dose; Phase 2: Week 1 and Week 5 pre-dose up to 8 hours post-dose
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after Tacabrutideg monotherapy
Measured: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose and 8 hours post-dose, Week 9 pre-dose; Phase 1b: Week 1 and Week 5 pre-dose and 6 hours post-dose, Week 9 pre-dose; Phase 2: Week 1, Week 5, Week 9 pre-dose
Phase 1: ORR
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL), Owen, and Lugano criteria.
Measured: Up to approximately 3 years
Phase 1: Major Response Rate (MRR) in participants with Waldenstrom macroglobulinemia (WM)
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), and partial response (PR), as assessed by investigators for participants with WM only.
Measured: Up to approximately 3 years
Phase 2: Number of participants with AEs and SAEs
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0).
Measured: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
Phase 2: Duration of Response (DOR) Participants with R/R CLL/SLL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and investigators.
Measured: Up to approximately 3 years
Phase 2: DOR in Participants with R/R MCL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by investigators.
Measured: Up to approximately 3 years
Phase 2: Time to Response (TTR) in Participants with R/R CLL/SLL
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by IRC and investigators.
Measured: Up to approximately 3 years
Phase 2: TTR in Participants with R/R MCL
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by investigators.
Measured: Up to approximately 3 years
Phase 2: Progression Free Survival (PFS) in Participants with R/R CLL/SLL
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by IRC and investigators.
Measured: Up to approximately 3 years
Phase 2: PFS in Participants with R/R MCL
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by investigators.
Measured: Up to approximately 3 years
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.
Measured: Up to approximately 3 years
Phase 2: Best Overall Response (BOR) of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
BOR of PR-L or better as determined by IRC and by investigators per iwCLL criteria for CLL and per Lugano criteria for SLL
Measured: Up to approximately 3 years
Phase 2: DOR of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and by investigators.
Measured: Up to approximately 3 years
Phase 2: TTR of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
TTR is defined as the time from study treatment start to date of the earliest qualifying response as determined by IRC and investigators.
Measured: Up to approximately 3 years
Phase 2: Change from baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) Disease-related Symptom Physical and Treatment Side Effect Subscales in participants with R/R MCL
The NFLymSI-18 questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. A mixed model for repeated measures (MMRM) will be used to estimate the mean change from baseline for NFlymSI-18 subscales of Disease-Related Symptoms Physical (DRSP), and "treatment side effects" (TSE).
Measured: Baseline; Day 1 of Weeks 5, 13, 25, and 37; 30 days after the last dose (up to approximately 3 years)
Phase 2: Mean change from baseline for the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu ) questionnaire Physical Well-being and Functional Well-being Subscales for participants with R/R CLL/SLL
FACT-Leu is a 44-item patient reported outcome questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. Each question is scored from 0 (not at all) to 4 (very much).
Measured: Baseline; Day 1 of Weeks 5, 13, 25, and 37; 30 days after the last dose (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start6 May 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294731
- Sponsor's protocol ID
- BGB-16673-102
- Other IDs
- CTR20220399
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.