Study BGB-11417-101 - BGB-11417 in patients with B-cell malignancies
Research type
Research Study
Full title
A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies
IRAS ID
300704
Contact name
Talha Munir
Contact email
Sponsor organisation
BeiGene, Ltd.
Eudract number
2020-004641-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 18 days
Research summary
This study aims to look at the safety and tolerability of an investigational anticancer medication, BGB-11417, in patients with B-cell malignancies including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), transformed non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM). It will also look at the safety of BGB-11417 when given in combination with zanubrutinib.
BGB-11417 blocks a protein (Bcl-2) which helps tumour cells live and grow. By blocking Bcl-2, BGB-11417 can slow or stop tumour cell growth and allow the body’s natural process to destroy unneeded cells. This might lead to an improvement in the symptoms associated with mature B-cell malignancies. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK). By blocking BTK, zanubrutinib may stop or slow down the growth and activity of B lymphocyte cells (type of white blood cell).
The study will independently investigate BGB-11417 both as a monotherapy (Parts 1 and 2) and in combination with zanubrutinib (Parts 3 and 4). The study will enrol approximately 227 to 284 (age 18 or older) patients in four parts. An estimated 139 to 178 patients will be treated with BGB-11417 monotherapy and an estimated 88 to 106 patients will be treated with BGB-11417 in combination with fixed dose zanubrutinib.
Participants will undergo various tests and procedures including blood and urine sampling, tumour and bone-marrow biopsies, electrocardiograms, echocardiograms Positron Emission Tomography (PET) / Computed Tomography (CT) scans, and physical examinations in order to evaluate and monitor their disease.
BeiGene, Ltd. is the sponsor for this study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0205
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion