Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT05471843

This clinical trial assesses the safety, tolerability, and efficacy of BGB-11417, an oral drug, in patients with relapsed or refractory mantle cell lymphoma. Eligible participants must have a confirmed MCL diagnosis, prior treatments including anti-CD20 therapy and BTK inhibitors, measurable disease, and adequate organ function. The study involves a dose-finding phase followed by an efficacy evaluation.

Patient Parameters

Program Overview

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Eligibility Criteria

Inclusion Criteria

  1. Histologically confirmed diagnosis of MCL
  2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
  3. Relapsed/refractory disease
  4. Presence of measurable disease
  5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  7. Adequate organ function

Key

Exclusion Criteria

  1. Known central nervous system involvement by lymphoma
  2. Prior malignancy other than MCL within the past 3 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 cancer.
  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
  4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
  5. Clinically significant cardiovascular disease.
  6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  7. Active fungal, bacterial or viral infection requiring systemic treatment.

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

Locations

FACILITYZIPCITYSTATE
University of Alabama At Birmingham Hospital35294BirminghamAlabama
Medstar Georgetown University Hospital20007WashingtonDistrict of Columbia
Fort Wayne Medical Oncology and Hematology46804Fort WayneIndiana
Des Moines Oncology Research Association50309Des MoinesIowa
Tulane Cancer Center70112New OrleansLouisiana
Luminis Health Anne Arundel Medical Center21401AnnapolisMaryland
Maryland Oncology Hematology, Pa21044ColumbiaMaryland
University of Missouri Hospital, Ellis Fischel Cancer Center65212ColumbiaMissouri
Nebraska Cancer Specialists68803Grand IslandNebraska
Dartmouth Cancer Center03756LebanonNew Hampshire

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