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

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

Recruiting
18 years and older
All
Phase 1

Overview

The purpose of this study is to determine the safety, tolerability; Recommended Phase 2 Dose (RP2D), optimal ramp-up dosing schedule; and to evaluate preliminary activity of BGB-11417 monotherapy.

Eligibility

Key Inclusion Criteria:

Part 1 Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters Transformation) that has relapsed or is refractory to at least 1 prior therapy

Part 2 (CLL/SLL Ramp-up):

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that relapsed or been refractory to at least 1 prior therapy

Part 2 (Expansion Cohorts):

Marginal Zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) or transformed B-cell NHL (excluding Richters Transformation) that has relapsed or is refractory to at least 1 prior therapy

Key Exclusion Criteria:

  1. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate
  2. Known central nervous system (CNS) involvement by lymphoma/leukemia
  3. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
  4. Prior autologous stem cell transplant unless 3 months after transplant
  5. Prior allogeneic stem cell transplant

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

Study details
    Mature B-Cell Malignancies

NCT04277637

BeiGene

16 February 2024

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