Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

BeiGene

Intervention(s):

  • Drug: BGB-11417
  • Drug: Zanubrutinib

Phase:

Phase 1

Eligibility


Key Inclusion Criteria:

1.

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 R/R disease defined as disease
   that relapsed after, or was refractory to, at least 2 prior therapies 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
   investigatorr

   WM cohorts:

   7. 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) 2.

Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined
as:

a. 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 b. DLBCL, FL,
MZL, 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. Adequate organ
function 5.

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:

   1. Known central nervous system involvement by lymphoma/leukemia

   2. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected
   Richter's syndrome

   3. 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jhina Patro
650-721-4094
Not Recruiting