A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Purpose
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)
Conditions
- B-cell Malignancy
- Marginal Zone Lymphoma
- Follicular Lymphoma
- Non-Hodgkin Lymphoma
- Waldenström Macroglobulinemia
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Diffuse Large B Cell Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
: 1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or 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
- 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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1a (Monotherapy Dose Escalation) |
Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), R/R follicular lymphoma (FL) Grades 1, 2, and 3a, R/R mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), R/R diffuse large B-cell lymphoma (DLBCL), R/R Richter's transformation (RT), and R/R Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673. |
|
|
Experimental Part 1b (Monotherapy Safety Expansion) |
Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673. |
|
|
Experimental Part 1c (Additional Monotherapy Safety Expansion) |
Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies. |
|
|
Experimental Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL) |
Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673. |
|
|
Experimental Part 1e (Japan-only Cohort) |
Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673. |
|
|
Experimental Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies) |
Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels. |
|
|
Experimental Phase 2 (Monotherapy Expansion) |
Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35294-0004
Scottsdale 5313457, Arizona 5551752 85258-4566
Tucson 5318313, Arizona 5551752 85724-0001
La Jolla 5363943, California 5332921 92093-1503
Palo Alto 5380748, California 5332921 94304-2205
Santa Monica 5393212, California 5332921 90404-2023
Fort Collins 5577147, Colorado 5417618 80528-3413
Jacksonville 4160021, Florida 4155751 32224-1865
Miami Beach 4164143, Florida 4155751 33140-2840
Tampa 4174757, Florida 4155751 33606-3571
Augusta 4180531, Georgia 4197000 30912-0002
Newnan 4212684, Georgia 4197000 30265-8001
Iowa City 4862034, Iowa 4862182 52242-1009
Baton Rouge 4315588, Louisiana 4331987 70809-3738
Bethesda 4348599, Maryland 4361885 20817-7847
Boston 4930956, Massachusetts 6254926 02215-5418
Detroit 4990729, Michigan 5001836 48201-2013
Rochester 5043473, Minnesota 5037779 55905-0001
Las Vegas 5506956, Nevada 5509151 89169-3321
Buffalo 5110629, New York 5128638 14203
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10065-4870
New York 5128581, New York 5128638 10065-6800
Chattanooga 4612862, Tennessee 4662168 37404
Nashville 4644585, Tennessee 4662168 37203
Houston 4699066, Texas 4736286 77030-3907
Richmond 4781708, Virginia 6254928 23298
Seattle 5809844, Washington 5815135 98109-4433
More Details
- NCT ID
- NCT05006716
- Status
- Recruiting
- Sponsor
- BeOne Medicines
Detailed Description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.