Study on the Safety and Effectiveness of BGB-16673 with Other Treatments for Relapsed or Refractory B-Cell Blood Cancers
Sponsor: BeiGene
ClinicalTrials ID:NCT06634589
This clinical trial is testing a new drug, BGB-16673, combined with other medications to see if it is safe and effective for patients with B-cell blood cancers that have returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and initial effectiveness of a new cancer drug, BGB-16673, when used with other treatments in patients with B-cell blood cancers that have come back or are resistant to treatment. The study is organized into different parts, each testing BGB-16673 with a different drug combination. Currently, there are four parts, and more may be added as new drug combinations are identified.
Description
This study is exploring how safe and effective a new drug, BGB-16673, is when used with other medications for treating B-cell blood cancers that have returned or are not responding to treatment. The study is divided into four parts, each testing BGB-16673 with a different drug: sonrotoclax, zanubrutinib, mosunetuzumab, and glofitamab. Each part of the study will help determine how well these combinations work and how safe they are for patients.
Eligibility Criteria
Inclusion Criteria
- Must agree to participate and sign a consent form.
- Have a confirmed diagnosis of relapsed or refractory B-cell blood cancer.
- Have a measurable disease as defined by the study.
- Be in stable health with a performance status score between 0 and 2.
- Have good organ function.
- Women who can become pregnant must use effective birth control and not donate eggs during the study and for a specified time after the last dose of the study drugs.
- Men must use effective birth control and not donate sperm during the study and for a specified time after the last dose of the study drugs.
- For parts 1, 3, and 4: Have good kidney function with a filtration rate of at least 50 mL/min.
- For part 2: Must not have been treated with a BTK inhibitor before, or have stopped using one for reasons other than cancer progression, and have good kidney function with a filtration rate of at least 30 mL/min.
Exclusion Criteria
- Have not been treated for B-cell blood cancer before.
- Cannot follow the study requirements.
- Have active brain or spinal cord cancer that is not controlled or treated.
- Have had any other cancer within 2 years before starting the study, except for the specific cancer being studied or any local cancer that has been treated and cured.
- Have had a stem cell transplant or CAR-T cell therapy within 3 months before the study.
- For parts 1 and 2: Have had a stem cell transplant with active graft-versus-host disease or need immunosuppressive drugs for it, or have used certain drugs within 4 weeks before the study.
- Have severe allergies to the study drugs or their ingredients.
- For part 1: Have been treated with a Bcl-2 inhibitor before, unless the cancer returned 24 months after finishing the treatment.
- For part 2: Have stopped taking zanubrutinib before due to intolerance.
- For parts 3 and 4: Have been treated with a CD20 x CD3 T-cell engager antibody before, or have had a stem cell transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Phoenix | 85254 | Phoenix | Arizona |
| University of Southern Californianorris Comprehensive | 90033 | Los Angeles | California |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
| Moffitt Cancer Center | 33612-9497 | Tampa | Florida |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| University of Michigan Health System | 48109 | Ann Arbor | Michigan |
| Mayo Clinic Rochester | 55905 | Rochester | Minnesota |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Summit Medical Group | 07932 | Florham Park | New Jersey |
| Weill Cornell Medical College Newyork Presbyterian Hospital | 10021 | New York | New York |
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