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Treatment for B-cell malignancies using BGB-16673

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

Phase1; Phase2 Interventional BeOne Medicines · NCT05294731

This study is testing a new drug called BGB-16673 to see if it can safely help people with different types of B-cell cancers.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment146 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Locations29 sites (Bengbu, Anhui and 28 other locations)
Trial IDNCT05294731 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety, tolerability, and preliminary antitumor activity of BGB-16673, a targeted protein degrader, in patients with various B-cell malignancies. The study is divided into two phases, with Phase 1 focusing on determining the recommended dose and Phase 2 evaluating its efficacy in specific B-cell malignancy cohorts. Participants will receive BGB-16673 monotherapy, and their responses will be assessed based on disease-specific criteria. The trial aims to provide insights into a novel treatment approach for these conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed diagnoses of specific B-cell malignancies such as MCL or CLL/SLL who meet the study's inclusion criteria.

Not a fit: Patients with prior malignancies (other than the disease under study) within the past two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with B-cell malignancies.

How similar studies have performed: Other studies have shown promise with targeted therapies in B-cell malignancies, suggesting potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria

1. Provision of signed and dated written informed consent prior to any study
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
4. 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
5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
6. 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

1. 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
2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
3. 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.
4. Current or history of central nervous involvement
5. 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

Where this trial is running

Bengbu, Anhui and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell MalignancyNon-Hodgkin LymphomaMantle Cell LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaWaldenström MacroglobulinemiaMarginal Zone LymphomaFollicular LymphomaDLBCL Unclassifiable
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.