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BGB-16673 Combination for B-Cell Lymphoma
Jacksonville, FL
Phase 1 & 2
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
* Confirmed diagnosis of a R/R B-cell malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess the safety and effectiveness of BGB-16673 in combination with other drugs in patients with relapsed or refractory B-cell cancers. The study will have different parts, with
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Who is the study for?
This trial is for adults with B-cell malignancies that have come back or didn't respond to treatment. They should not have tried Bruton tyrosine kinase inhibitors, or if they did, stopped without disease progression. Participants need a confirmed diagnosis, be relatively active (ECOG 0-2), and have organs working well. They must understand the study and agree to its rules, including birth control measures.Check my eligibility
What is being tested?
The trial tests BGB-16673 combined with other drugs in people with relapsed/refractory B-cell cancers. It's organized into substudies within a master protocol; initially featuring two substudies but may include more later on. The focus is on safety, cancer-fighting ability, how the body processes the drugs (pharmacokinetics), and their effects on the body (pharmacodynamics).See study design
What are the potential side effects?
Specific side effects are not listed here but typically for cancer treatments like these could include fatigue, nausea, diarrhea, risk of infection due to lowered blood counts, liver issues among others depending upon individual patient response and specific drug profiles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Key
Select...
I have a confirmed relapsed or refractory B-cell cancer.
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Select...
My physical health allows me to care for myself and perform daily activities.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Substudy 1 Part 1a and 1b: Duration of Response (DOR) for BGB-16673 and sonrotoclax
Substudy 1 Part 1a and 1b: Overall Response Rate (ORR) for BGB-16673 and sonrotoclax
Substudy 1 Part 1a and 1b: Time to Response (TTR) for BGB-16673 and sonrotoclax
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Substudy 2 Part 1b: Safety ExpansionExperimental Treatment2 Interventions
Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell histologies.
Group II: Substudy 2 Part 1a: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated.
Group III: Substudy 1 Part 1b: Safety ExpansionExperimental Treatment2 Interventions
Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell histologies.
Group IV: Substudy 1 Part 1a: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~2360
sonrotoclax
2024
Completed Phase 1
~30
Find a Location
Closest Location:The University of Kansas Cancer Center· Westwood, KS· 196 miles
Who is running the clinical trial?
BeiGeneLead Sponsor
215 Previous Clinical Trials
32,438 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,311 Previous Clinical Trials
572,939 Total Patients Enrolled