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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

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

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I have a confirmed relapsed or refractory B-cell cancer.

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My physical health allows me to care for myself and perform daily activities.

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

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