Education and Training

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: BGB-16673

Eligibility


Inclusion Criteria :

   1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise
   noted) of one of the following: Marginal Zone Lymphoma (MZL) , Follicular Lymphoma
   (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia and small
   lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuse large
   B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation to DLBCL.

   2. Participants who have previously received a covalently-binding Bruton´s tyrosine
   kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with
   the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).

   3. For dose-finding and dose-expansion, participants who had previously received a
   covalently-binding BTK inhibitor as monotherapy or in combination with other
   anticancer agents are eligible for the study if they meet any of the following
   criteria: discontinued the previous BTK inhibitor due to disease progression,
   experienced disease progression after completing treatment with a BTK inhibitor or
   discontinued the BTK inhibitor due to toxicity or intolerance.

   4. Measurable disease by radiographic assessment or serum IgM level (WM only)

   5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

   6. Participants enrolling in the dose finding phase of the study may be previously
   treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and
   country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase
   2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL
   participants, in addition to being treated with a BTKi in a prior line of therapy,
   must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase
   2).

Exclusion Criteria:

   1. Prior malignancy (other than the disease under study) within the past 2 years, except
   in situ malignancies that have been curatively resected, localized breast cancer
   treated with curative intent with no evidence of breast active disease for more than 3
   years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate
   cancer undergoing observation or treatment with androgen depravation, or any other
   cancer treated with curative intent, not on adjuvant treatment, and in the opinion of
   the investigator is unlikely to recur.

   2. Requires ongoing systemic treatment for any other malignancy

   3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)
   corticosteroid treatment.

   4. Current or history of central nervous system involvement including the brain, spinal
   cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
   biopsy) by B-cell malignancy, regardless of whether participants had received
   treatment for central nervous system disease

   5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt
   lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman
   disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal
   center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous
   system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic
   inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large
   B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade
   B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell
   lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between
   DLBCL and classical Hodgkin lymphoma, or history of or currently suspected
   transformation of an indolent lymphoma to an aggressive histology (except for
   participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or
   Phase 2 and participants with history of follicular lymphoma transforming to non-GCB
   DLBCL who are eligible for Part 1a, 1c, or Phase 2).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrew Nguyen Le
ankhle@stanford.edu
I'm interested