← Back to Search

Other

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

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.
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).
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 below
Select...
I have a confirmed relapsed or refractory B-cell cancer.
Select...
My physical health allows me to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Substudy 1 Parts 1a and 1b: Duration of Response (DOR)
Substudy 1 Parts 1a and 1b: Overall Response Rate (ORR) in participants with B-cell malignancies
Substudy 1 Parts 1a and 1b: Time to Response (TTR)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Substudy 4 Part 1b: Safety ExpansionExperimental Treatment3 Interventions
Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.
Group II: Substudy 4 Part 1a: Dose EscalationExperimental Treatment3 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
Group III: Substudy 3 Part 1b: Safety ExpansionExperimental Treatment2 Interventions
Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Group IV: Substudy 3 Part 1a: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Group V: 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 malignancies.
Group VI: Substudy 2 Part 1a: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Group VII: 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 malignancies.
Group VIII: Substudy 1 Part 1a: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~2360
Mosunetuzumab
2019
Completed Phase 2
~160
Glofitamab
2021
Completed Phase 1
~170
Obinutuzumab
2014
Completed Phase 3
~3640

Find a Location

Closest Location:Mayo Clinic Jacksonville· Jacksonville, FL

Who is running the clinical trial?

BeiGeneLead Sponsor
215 Previous Clinical Trials
32,438 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,313 Previous Clinical Trials
573,089 Total Patients Enrolled
~53 spots leftby Dec 2028