Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

Launched by BEIGENE · Feb 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-11417 for patients with certain types of blood cancers known as mature B-cell malignancies. The main goals of the trial are to find out how safe this treatment is, how well patients can tolerate it, and to identify the highest dose that can be given to patients without causing severe side effects. The study will also look at how BGB-11417 works on its own and when combined with other treatments called zanubrutinib and obinutuzumab.

To be eligible for this trial, participants should have a confirmed diagnosis of specific blood cancers, such as non-Hodgkin lymphoma or chronic lymphocytic leukemia, and must have had previous treatments that did not work or were not successful. Participants should also have measurable disease that can be seen on scans and should be in generally good health. During the trial, patients will receive the study drug and will be closely monitored for any side effects or changes in their condition. If you think you might qualify or want to learn more, it’s important to discuss this with your doctor.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• * Confirmed diagnosis of one of the following:
• NHL Cohorts:
• • 1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
• • 2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
• • 3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
• • 4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
• CLL/SLL Cohorts:
• • 5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
• MCL cohorts:
• • 6. WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
• WM cohorts:
• • g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)
• * Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
• • 1. CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
• • 2. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
• • 3. WM: serum immunoglobulin (Ig) M level \> 0.5 g/dL
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• • Adequate organ function
• * Adequate pancreatic function indicated by:
• • 1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)
• • 2. Serum lipase ≤ 1.5 x ULN
• Key Exclusion Criteria:
• • Known current central nervous system involvement by lymphoma/leukemia
• • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
• • Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.