Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
Sonrotoclax: Film-coated tablets administered once daily at a dose as specified in the treatment arm
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)
Obinutuzumab: Given as an intravenous infusion administered per label.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) — Up to 30 days after the last dose of study drug, an average of 18 months
- Number of Participants Experiencing Serious Adverse Events (SAEs) — Up to 30 days after the last dose of study drug, an average of 18 months
- Number of Participants Experiencing Adverse Events (AEs) leading to discontinuation of Sonrotoclax — Up to 30 days after the last dose of study drug, an average of 18 months
- Part 1, Part 3: Maximum Tolerated Dose (MTD) of Sonrotoclax — Up to approximately 2 months
- Part 1, Part 3, Part 5: RP2D of Sonrotoclax — Day 1 to last dose of study drug, an average of 18 months
- Part 1, Part 3, Part 5: Number of participants experiencing tumor lysis syndrome (TLS) relevant events — Up to 30 days after the last dose of study drug, an average of 18 months
- Part 1, Part 3, Part 5: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs — Up to approximately 2 months
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Hematologyoncology | Los Angeles | California | |
| Northwestern University | Chicago | Illinois | |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| John Theurer Cancer Center Hackensack University Medical Center | Hackensack | New Jersey | |
| Columbia University Medical Center | New York | New York | |
| Memorial Sloan Kettering Cancer Center Mskcc | New York | New York | |
| The James Cancer Hospital and Solove Research Institute At Ohio State University | Columbus | Ohio | |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) | Pittsburgh | Pennsylvania | |
| Md Anderson Cancer Center | Houston | Texas | |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | |
| Concord Repatriation General Hospital | Concord | New South Wales | |
| Orange Health Service (Central West Cancer Care Centre) | Orange | New South Wales | |
| Pindara Private Hospital | Benowa | Queensland | |
| John Flynn Private Hospital | Tugun | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Flinders Medical Centre | Bedford PK | South Australia | |
| Box Hill Hospital | Box Hill | Victoria | |
| Monash Health | Clayton | Victoria | |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | |
| The Alfred Hospital | Melbourne | Victoria | |
| Linear Clinical Research | Nedlands | Western Australia | |
| Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden | Dresden | Germany | |
| Ospedale San Raffaele | Milan | Italy | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | Italy | |
| Ospedale Santa Maria Della Misericordia | Perugia | Italy | |
| Azienda Unita Sanitaria Locale Di Ravenna | Ravenna | Italy | |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | Italy | |
| Centroricerche Cliniche Di Verona Srl | Verona | Italy | |
| North Shore Hospital | Auckland | New Zealand | |
| Auckland City Hospital | Auckland | New Zealand | |
| Wellington Regional Hospital (Ccdhb) | Wellington | New Zealand | |
| Vall D Hebron Institute of Oncology Vhio | Barcelona | Spain | |
| Hospital Clinic de Barcelona | Barcelona | Spain | |
| Hospital de La Santa Creu I Sant Pau | Barcelona | Spain | |
| Ico H Duran I Reynals | Barcelona | Spain | |
| Start Madrid Fundacion Jimenez Diaz | Madrid | Spain |
+ 3 more sites — see the full list on the official registry below.
On this site
📄 Brukinsa (zanubrutinib) drug profile →More BeOne Medicines trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04277637 on ClinicalTrials.gov ↗ ← All trials in Spain