For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria

  1. Provision of signed and dated written informed consent prior to any study, Age ≥ 18 years
  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. Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia, small lymphocytic lymphoma, WM, diffuse large B-cell lymphoma (DLBCL) (part 1a only), or Richter's transformation to DLBCL (part 1a only).
  5. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug

EXCLUSION CRITERIA

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, or proton-pimp inhibitors ≤ 14 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

B-cell Malignancy,Non-Hodgkin Lymphoma,Mantle Cell Lymphoma,Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,Waldenström Macroglobulinemia,Marginal Zone Lymphoma,Follicular Lymphoma,DLBCL Unclassifiable,Richter's Transformation

Age (in years)

18+

Phase

Phase 1

Participants needed

116

Est. Completion Date

Mar 31, 2027

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT05294731

Study number

BGB-16673-102

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