ClinicalTrials.gov record NCT05294731

Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2 open-label study evaluates oral BGB-16673 in Chinese patients with several B‑cell malignancies (for example MCL, CLL/SLL, FL, MZL, WM, and DLBCL). Phase 1 escalates doses to find a recommended Phase 2 dose and assess safety and tolerability; Phase 2 gives that dose in expansion cohorts to evaluate preliminary anti-tumor activity. The trial is randomized, uses parallel groups, and is not masked (open-label).

What it is studying. The study tests oral BGB-16673, a Bruton Tyrosine Kinase-targeted protein-degrader, as a single agent to identify a recommended Phase 2 dose and to assess safety, drug levels, BTK protein degradation, and preliminary anti-tumor activity in selected B‑cell malignancies.

What the researchers hope to learn. To find a recommended Phase 2 dose (RP2D) of BGB-16673 and to collect safety and tolerability data; to measure pharmacokinetics and BTK protein degradation; and to evaluate preliminary anti-tumor activity outcomes such as response rates, duration of response, progression-free survival, and overall survival.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • BGB-16673

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Provision of signed and dated written informed consent prior to any study
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
  • 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 at least 90 days after the last dose of the study drug
  • Key

Exclusion criteria

  • 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
  • Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
  • 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take the study drug BGB‑16673 by mouth and attend regular clinic visits for safety monitoring and disease assessments. The study involves frequent blood sampling for drug levels and for measuring Bruton's tyrosine kinase (BTK) protein, plus tumor/response evaluations using disease‑specific criteria; safety is followed during treatment and for 30 days after the last dose, with some outcomes followed for up to about 3 years. You will need to avoid certain medicines before starting (strong CYP3A inhibitors/inducers and proton‑pump inhibitors as specified) and use highly effective birth control during treatment and for at least 90 days after the last dose.

How the study is structured. An interventional Phase 1/2 treatment trial with dose-escalation (Phase 1) and dose-expansion (Phase 2) parts. Participants receive oral BGB-16673 as monotherapy; the study is randomized, conducted in parallel groups, and open-label (no masking).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 6, 2022
Primary completion
Jan 31, 2029 (estimated)
Study completion
Jan 31, 2029 (estimated)
Target enrollment
146 participants (estimated)
Last updated on registry
Aug 21, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
BeiGene

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (29)

  • The First Affiliated Hospital of Bengbu Medical UniversityRecruiting

    Bengbu, Anhui, 233004 · China

  • Anhui Provincial HospitalRecruiting

    Hefei, Anhui, 230000 · China

  • Peking University Third HospitalRecruiting

    Beijing, Beijing Municipality, 100000 · China

  • Beijing Chao Yang Hospital,Capital Medical UniversityRecruiting

    Beijing, Beijing Municipality, 100020 · China

  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)Recruiting

    Chongqing, Chongqing Municipality, 400037 · China

  • Fujian Medical University Union HospitalRecruiting

    Fuzhou, Fujian, 350001 · China

  • Sun Yat Sen University Cancer CenterRecruiting

    Guangzhou, Guangdong, 510060 · China

  • Guangdong Provincial Peoples Hospital Huifu BranchRecruiting

    Guangzhou, Guangdong, 510120 · China

  • The Peoples Hospital of Guangxi Zhuang Autonomous RegionRecruiting

    Nanning, Guangxi, 530021 · China

  • Nanyang Central HospitalRecruiting

    Nanyang, Henan, 473000 · China

Terms used on this page · explanations by MedicalUpdates.ai

recommended phase 2 dose
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Phase 2
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
autologous stem cell transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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