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