Trials / Active Not Recruiting
Active Not RecruitingNCT04277637
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- BeOne Medicines · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sonrotoclax | Film-coated tablets administered once daily at a dose as specified in the treatment arm |
| DRUG | Zanubrutinib | 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) |
| DRUG | Obinutuzumab | Given as an intravenous infusion administered per label. |
Timeline
- Start date
- 2020-03-24
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
- First posted
- 2020-02-20
- Last updated
- 2026-03-27
Locations
43 sites across 7 countries: United States, Australia, Germany, Italy, New Zealand, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04277637. Inclusion in this directory is not an endorsement.