Treatment for B-cell malignancies using BGB-16673

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate hematologic, coagulation, renal, pancreatic, and hepatic function, and measurable disease according to disease-specific criteria, as applicable
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 ≥ 30 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. Current or history of central nervous involvement
4. 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 it's running

• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Chao Yang Hospital,Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: BeOne Medicines
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exploring BGB-16673 for treating B-cell malignancies

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• Oral AS-1763 treatment for patients with certain blood cancers

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• Using CD79b-19 CAR T cells to treat Non-Hodgkin Lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.