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Small Molecule Inhibitor

BGB-16673 for B-Cell Cancers

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

Confirmed diagnosis of Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), R/R MCL, R/R CLL/SLL, WM, DLBCL, or >2 treatments per the Richter's transformation to DLBCL

Participants who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is effective and how it works in combination with other drugs.

Who is the study for?

This trial is for people with certain B-cell malignancies, including various types of lymphoma and leukemia. Participants must have measurable disease, may have had previous treatments (specific conditions apply), and should be in a relatively stable condition as indicated by an ECOG score of 0 to 2. Those who've had other cancers within the last two years or require ongoing treatment for another cancer are not eligible.Check my eligibility

What is being tested?

The study tests BGB-16673's optimal dosing levels in two parts: first, finding the right dose through monotherapy escalation; second, expanding safety studies at selected doses. It aims to determine how well this drug can treat different B-cell malignancies when given alone.See study design

What are the potential side effects?

While specific side effects for BGB-16673 aren't listed here, similar drugs often cause fatigue, digestive issues like nausea or diarrhea, blood disorders such as low platelet counts or anemia, infections due to weakened immune systems, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of lymphoma or have had more than 2 treatments for Richter's transformation.

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I was treated with a BTK inhibitor for at least 8 weeks, unless I couldn't tolerate it.

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I can take care of myself and am up and about more than half of my waking hours.

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I may or may not have had BTKi therapy, depending on my diagnosis and where I live.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of BGB-16673

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and Adverse Events (AEs) graded according NCI-CTCAE V5.

Part 2: ORR in relapsed/refractory chronic/small lymphocytic lymphoma (R/R CLL/SLL) Participants

+2 more

Secondary outcome measures

Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy

Part 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR)

Part 1: Overall response rate (ORR)

+26 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2 (Monotherapy Dose Expansion)Experimental Treatment1 Intervention

The totality of the data from Part 1a and Part 1b will be used to further evaluate the safety and efficacy of BGB-16673 at the recommended dose(s) for Part 2 expansion in specific histologies.

Group II: Part 1c (Additional Monotherapy Safety Expansion)Experimental Treatment1 Intervention

After RP2D is determined, additional safety data will be collected to confirm RP2D for participants with selected B-cell malignancies not being evaluated in Part 2

Group III: Part 1b (Monotherapy Safety Expansion)Experimental Treatment1 Intervention

Additional participants with selected R/R B-Cell malignancies will be enrolled at selected doses to help inform the selection of the recommended phase two dose (RP2D).

Group IV: Part 1a (Monotherapy Dose Escalation)Experimental Treatment1 Intervention

Dose escalation in selected R/R B-Cell malignancies to inform safety, tolerability and MTD.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,523 Total Patients Enrolled

Media Library

BGB-16673 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05006716 — Phase 1 & 2

B-Cell Cancers Research Study Groups: Part 1a (Monotherapy Dose Escalation), Part 1b (Monotherapy Safety Expansion), Part 1c (Additional Monotherapy Safety Expansion), Part 2 (Monotherapy Dose Expansion)

B-Cell Cancers Clinical Trial 2023: BGB-16673 Highlights & Side Effects. Trial Name: NCT05006716 — Phase 1 & 2

BGB-16673 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006716 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a substantial number of facilities conducting this research within the state?

"Presently, this research study is being conducted at 7 distinct sites located in Phoenix, Rochester and Jacksonville amongst other regions. Participants may want to select the closest centre to lessen travel needs should they choose to take part."

Answered by AI

Has the Food and Drug Administration endorsed BGB-16673 for use?

"There is limited evidence of BGB-16673's safety and efficacy, meaning it was assigned a modest score of 1."

Answered by AI

Are there any remaining openings for participants in this clinical trial?

"According to the clinicaltrials.gov website, this experiment has been accepting participants since its inception on September 13th 2021 and is still recruiting as of October 24th 2022."

Answered by AI

How many participants have signed up for the research project?

"Affirmative. Clinicaltrials.gov has data that indicates this clinical trial is still searching for participants, which was first advertised on September 13th 2021 and modified most recently on October 24th 2022. The study has the capacity to accept 76 subjects from 7 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

2021. "A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006716.

All > Waldenstrom Macroglobulinemia