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

Conditions

• B-cell Malignancy
• Chronic Lymphocytic Leukemia
• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Non-Hodgkin Lymphoma
• Small Lymphocytic Lymphoma
• Waldenström Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BGB-16673 — DRUG
  Orally administered

Study Details

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)

Key Dates

Start date

Sep 13, 2021

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2029

Study Design

Enrollment

645 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Phase 1: Number of Participants with Adverse Events (AEs) [ Time Frame: From the first dose of BGB-16673 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks) ]

Central Contacts

• BeOne Medicines
  1.877.828.5568
  [email protected]
• Study Director, MD

Locations (31)

Find similar trials in Birmingham, AL

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