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Bcl-2 Inhibitor

BGB-11417 +/− Zanubrutinib for B-Cell Lymphoma

Phase 1
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 NHL Cohorts:
Adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 21 days target dose of the study drug, an average of 18 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, BGB-11417, to see if it is safe and effective when used alone or in combination with another cancer drug, zanubrutinib.

Who is the study for?
This trial is for adults with certain types of B-cell lymphoma who have relapsed or didn't respond to previous treatments. They must have measurable disease, be in fair health (ECOG 0-2), and their organs must function well. People with brain involvement by lymphoma, prior Bcl-2 inhibitor treatment failure, plasma cell neoplasm, prolymphocytic leukemia, or suspected Richter's syndrome can't join.Check my eligibility
What is being tested?
The study tests the safety and ideal dosing of a new drug called BGB-11417 alone and combined with zanubrutinib and obinutuzumab. It aims to find the highest dose patients can take without serious side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D).See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, fatigue, nausea, diarrhea; specific risks will become clearer as more people participate.

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 non-Hodgkin lymphoma.
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My organs are working well.
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My Waldenström's macroglobulinemia has returned or didn't respond to my first treatment.
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My mantle cell lymphoma has returned or didn't respond to at least one treatment.
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My DLBCL cancer returned or didn't respond after 2 treatments and I can't have a stem cell transplant.
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I have been diagnosed with CLL or SLL.
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I have a lymph node larger than 1.5 cm or an extranodal lesion larger than 1.0 cm.
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My condition either hasn't been treated yet or didn't respond to at least one prior treatment.
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My slow-growing B-cell lymphoma has become more aggressive, but it did not start as CLL or SLL.
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I have CLL with a lymph node larger than 1.5 cm or detectable cancer cells in my blood.
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My pancreas is working well.
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My CLL/SLL diagnosis meets international standards.
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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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My follicular lymphoma has returned or didn't respond after at least one treatment.
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My marginal zone lymphoma has returned or didn't respond to treatment and needs more therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 21 days target dose of the study drug, an average of 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 21 days target dose of the study drug, an average of 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Adverse Events (AEs) leading to discontinuation of BGB-11417
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
+3 more
Secondary outcome measures
Apparent Clearance (CL/F) of BGB-11417
Apparent volume of distribution (Vz/F) of BGB-11417
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of BGB-11417
+15 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: BGB-11417 Monotherapy Expansion Cohorts: Part 2Experimental Treatment1 Intervention
Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral BGB-11417 at the RP2D dose to further define the safety profile
Group II: BGB-11417 Monotherapy Dose Finding: Part 1Experimental Treatment1 Intervention
Participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL) or transformed NHL, mantle cell lymphoma (MCL); Waldenströms macroglobulinemia (WM); and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive oral BGB-11417 until the maximum tolerated dose (MTD) (or maximum ascending dose (MAD)) and recommended phase 2 dose can be determined
Group III: BGB-11417 + Zanubrutinib Combination Therapy Dose Finding: Part 3Experimental Treatment2 Interventions
Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; R/R MCL; R/R or treatment-naïve (TN) CLL/SLL will receive oral BGB-11417 until RP2D can be determined in combination with zanubrutinib
Group IV: BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 6Experimental Treatment3 Interventions
Participants with treatment naïve CLL/SLL will receive oral BGB-11417 at an RP2D dose to further define the safety profile in combination with obinutuzumab without and with zanubrutinib
Group V: BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 4Experimental Treatment2 Interventions
Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; R/R MCL; R/R or treatment-naïve (TN) CLL/SLL will receive oral BGB-11417 at an RP2D dose to further define the safety profile in combination with zanubrutinib
Group VI: : BGB-11417 + Zanubrutinib Combination Therapy Dose Escalation: Part 5Experimental Treatment2 Interventions
Participants with treatment naïve CLL/SLL will receive oral BGB-11417 until RP2D can be determined in combination with obinutuzumab without and with zanubrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
obinutuzumab
2018
Completed Phase 3
~2630
Zanubrutinib
2017
Completed Phase 2
~1270

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
174 Previous Clinical Trials
28,186 Total Patients Enrolled
David SimpsonStudy DirectorBeiGene
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

BGB-11417 (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04277637 — Phase 1
B-Cell Lymphoma Clinical Trial 2023: BGB-11417 Highlights & Side Effects. Trial Name: NCT04277637 — Phase 1
BGB-11417 (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04277637 — Phase 1
B-Cell Lymphoma Research Study Groups: : BGB-11417 + Zanubrutinib Combination Therapy Dose Escalation: Part 5, BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 6, BGB-11417 Monotherapy Dose Finding: Part 1, BGB-11417 Monotherapy Expansion Cohorts: Part 2, BGB-11417 + Zanubrutinib Combination Therapy Dose Finding: Part 3, BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 4

Frequently Asked Questions

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

To what extent can BGB-11417 pose a hazard to humans?

"This compound's safety profile is still relatively unproven, warranting a score of 1. BGB-11417 has only been tested in Phase 1 trials, which means there are limited data to back up its purported efficacy and safety."

Answered by AI

Is enrollment for this research still open to participants?

"Per the clinicaltrials.gov records, this research is actively seeking volunteers; it was initially published on March 24th 2020 and its details have been updated most recently on July 6th 2022."

Answered by AI

Has prior research been conducted on BGB-11417?

"Currently, 137 trials of BGB-11417 are being conducted with 25 in the third phase. While most studies involving this medication are taking place in Nanning, Guangxi there is a total of 3276 sites running related clinical tests."

Answered by AI

Is this medical study a pioneering endeavor?

"Currently, 137 trials for BGB-11417 are in progress across 611 municipalities and 49 nations. MEI Pharma, Inc. conducted the inaugural trial of this medication back in 2016 with 177 patients as part of its Phase 1 evaluation process; since then, 30 studies have been concluded successfully."

Answered by AI

What is the current number of participants in this clinical research?

"Indeed, clinicaltrials.gov indicates that the current search for participants is ongoing. This medical research was originally posted on March 24th 2020 with its last edit taking place on July 6th 2022. With 8 sites in operation, 418 patients must still be recruited to participate."

Answered by AI

To what medical issues is BGB-11417 typically applied?

"BGB-11417 is a viable therapy for waldenstrom's macroglobulinemia, relapsed marginal zone lymphoma and select types of lymphoma."

Answered by AI

How many separate sites are managing this research endeavor?

"This medical study is currently being conducted in a total of 8 different sites, including Seattle, Houston and Stanford. To reduce the burden of travelling to participate, it may be beneficial for potential candidates to select the closest location available."

Answered by AI
~247 spots leftby Aug 2027