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

Purpose

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.

Conditions

  • Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma (MCL)
  • Relapsed Mantle Cell Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Arm 		Participants will receive sonrotoclax
  • Drug: BGB-11417
    Administered orally
    Other names:
    • sonrotoclax

Recruiting Locations

Tulane Cancer Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
BeiGene

Study Contact

BeiGene
1.877.828.5568
clinicaltrials@beigene.com