Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The study will evaluate how safe and tolerable a Bcl-2 Inhibitor called BGB-21447 is, as well as determine the maximum tolerated dose (MTD), maxium administered dose (MAD), recommended Phase 2 dose (RP2D), and how the body interacts. Additionally, preliminary anti-tumour activity will be assessed. This study is divided into two main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion".
Part 1 will have two cohorts:
- Cohort A1 will enrol participants with B-cell non-Hodgkin lymphoma (NHL), including DLBCL, FL, MZL, B-NHL and Richter's transformation to DLBCL.
- Cohort B will enrol people with relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL)
In both cohorts, participants will receive BGB-21447 orally once a day.
In Part 2 (Cohort A2), participants will receive BGB-21447 with up to two dose levels from Cohort A1 for further evaluation of safety and efficacy.
Conditions
This trial is treating people with mature B-cell malignancies, including diffuse large b-cell lymphoma, follicular lymphoma, marginal zone lymphoma, transformed B-cell non-Hodgkin lymphoma, Richter's transformation to diffuse large B-cell lymphoma.
Eligibility
Inclusion
-
Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:
Cohort A1 and Cohort A2:
- R/R DLBCL
- R/R FL
- R/R MZL
- Transformed B-cell NHL
- Richter's transformation to DLBCL
- Measurable disease by computed tomography/magnetic resonance imaging.
Exclusion
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
- Known central nervous system involvement by lymphoma/leukemia
- Prior autologous stem cell transplant < 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months before the first dose of study drug
- Prior allogeneic stem cell transplant.
- Major surgery < 4 weeks before the first dose of study treatment
NOTE: Other Inclusion/Exclusion criteria may apply.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene
Scientific Title
A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
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