CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 437 enrolled / 437 target
Drug / intervention
Sonrotoclax +2 moredrug
Likely dose
Zanubrutinib 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04277637
NCT04277637Phase 1ActiveMonitor (5.8/mo)
CompareCT.gov

A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

BeOne Medicines·interventional·Posted Feb 20, 2020·Updated Jun 22, 2026

In Brief

A Phase 1 clinical trial evaluating Sonrotoclax, Zanubrutinib, and 1 other intervention for Mature B-Cell Malignancies. Active but no longer recruiting, targeting 437 participants across 43 sites in 7 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMature B-Cell Malignancies
CountriesAustralia, Germany, Italy, New Zealand, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1Active
20202021202220232024202520262027
First PostedFeb 20, 2020
Enrollment StartMar 24, 2020
Primary CompletionMay 31, 2027
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 6.4 years agoPrimary completion in 11 months

Arms & Interventions

Sonrotoclax Monotherapy Dose Finding: Part 1experimental

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 sonrotoclax evaluated as monotherapy.

Drug: Sonrotoclax
Sonrotoclax Monotherapy Expansion Cohorts: Part 2experimental

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 sonrotoclax at the RP2D dose to further define the safety profile.

Drug: Sonrotoclax
Sonrotoclax + Zanubrutinib Combination Therapy Dose Finding: Part 3experimental

Participants with R/R MCL, R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib.

Drug: SonrotoclaxDrug: Zanubrutinib
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 4experimental

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 sonrotoclax in combination with zanubrutinib at an RP2D dose to further define the safety profile.

Drug: SonrotoclaxDrug: Zanubrutinib
Sonrotoclax + Zanubrutinib Combination Therapy Dose Escalation: Part 5experimental

Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib.

Drug: SonrotoclaxDrug: ZanubrutinibDrug: Obinutuzumab
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 6experimental

Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib at an RP2D dose to further define the safety profile.

Drug: SonrotoclaxDrug: ZanubrutinibDrug: Obinutuzumab

Interventions

Sonrotoclaxdrug

Film-coated tablets administered once daily at a dose as specified in the treatment arm

Zanubrutinibdrug

320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)

Obinutuzumabdrug

Given as an intravenous infusion administered per label.